By Jeanne Yacoubou, MS

The Vegetarian Resource Group received an email inquiry from Theresa with a question about ingredients in pain relievers. She wrote:

“I went shopping yesterday for Tylenol and Motrin…Tylenol and Excedrin Migraine both had pregelatinized starch in them…I have three bottles of Excedrin Migraine and two do not have that ingredient. I called both companies and…was…told that it was high quality bovine gelatin—GREAT! I can’t believe that gelatin is…a needed ingredient in pain killers…Just thought it was weird that only one out of three products had that ingredient…

…I did find an alternative solution for now. The Target® brand of tension headache medication did not have gelatin in it.

Thanks for your continued research into this.”

Pain Reliever Ingredients
When analyzing the entire ingredient statements for these products, the first thing that we noticed was a major difference between tablet and gel capsule formulations.

Tablets may contain pregelatinized starch which is never animal-derived. (See next section for more about this ingredient.) Gel capsules most often contain gelatin (thus, their name) which is animal-derived. Despite their seemingly similar names, however, these two ingredients are not the same. [VRG Note: Gelatin alternatives that are vegan exist. Seaweed-derived agar agar may serve as a suitable substitute for gelatin. Hydroxypropyl methylcellulose (HPMC or hypromellose), sourced from wood or cotton with petrochemical-derived parts, is another vegan alternative to gelatin.] See: http://www.orisonchem.com/hpmc.html

Pregelatinized Starch in Foods
“Pregelatinized” refers to the process by which an ingredient such as starch or flour is pre-cooked, dried, and ground into flake or powder form. Pregelatinized starch is widely used in the food industry (soup mixes, sauces, etc.). Its ability to dissolve in cold liquids and achieve viscosity simplifies the manufacturing process. The most common starches used are corn, tapioca, and potato starches.

Diane Andrick in the Customer Advocacy Department of Tate & Lyle Ingredients Americas LLC, a major manufacturer of pregelatinized starch, told The VRG in November 2017:
“Gelatinizing starches allow them to be used in different food applications than starches that are processed otherwise.

I can assure you that no gelatin is used in the production of our prejel starches. They are all both kosher- and halal- certified. Halal certification is not given to products using gelatin. Our T&L products are vegan and vegetarian. The vegetarian status below is on our specification sheet [for our product Miragel® 463].
Vegetarian Status
vegetarian: suitable
vegan: suitable
ovo-vegetarian: suitable
lacto-vegetarian: suitable
lacto-ovo-vegetarian: suitable”
https://www.tateandlyle.com/ingredient/mira-gel-starch

Pregelatinized Starch in Pharmaceuticals
In the pharmaceutical industry, pregelatinized starch is commonly used as a binder in tablet manufacturing. There are other functions as well. See, for example, this weblink for more information starting on the bottom of page 2548 and following: http://www.jpharmsci.org/article/S0022-3549(15)00249-X/pdf
See also: https://www.colorcon.com/products-formulation/all-products/excipients/tablets/starch-1500

Pregelatinized starches also have many other applications such as in the mining, textile, and construction industries: http://www.grainprocessing.com/industrial-starch-products/pregelatinized-starches.html

To learn more about pregelatinized starches:
https://www.cargill.com/food-bev/ap/pregelatinized-starches
http://www.galam.co.il/food-beverages/products/pre-gelatinized-starches
http://www.paramesubiotech.com/pregelatinized-maize-starch-food-grade.htm
http://www.viscostarch.com/pregelatinized-starch-food.php

VRG Comment on Theresa’s Inquiry
Based on our research into pregelatinized starch, VRG inquirer Theresa received inaccurate information when she called pain reliever companies about pregelatinized starch. It is not from bovine gelatin. Below is what we learned from several companies which manufacture pain relievers when we called in November 2017.

Tylenol
We first submitted a contact request form on Tylenol’s website about pregelatinized starch and magnesium stearate. We received a reply:
“At this time, we unfortunately do not have that information available to us at the Consumer Care Center.”

In order to obtain some ingredient information we then called Johnson & Johnson® manufacturer of Tylenol. We asked specifically about their Cold + Flu Severe® caplets containing pregelatinized starch and magnesium stearate:
https://www.tylenol.com/products/tylenol-cold-flu-severe-caplets#ingredients

The customer Service Representative told us that their pregelatinized starch was “plant-based starch.”

We then asked about magnesium stearate. She read from her database:
“Q: ‘Does this product contain animal or animal byproducts?’ A: ‘No.’”
She did not have specific information on magnesium stearate.

Excedrin
The VRG first submitted a contact request form on Excedrin’s website about its ingredients. The email reply instructed us to call their consumer line for information.

So we called GlaxoSmithKline® manufacturer of Excedrin. We wanted to know more about the ingredients in:
https://www.excedrin.com/content/dam/cf-consumer-healthcare/excedrin/en_US/documents/PM_DRUGFACTS_0923.pdf#zoom=100

Readers may note the disclaimer at the top of the first page in this weblink that states that when a product’s label ingredients differ from what is on the website for that product, the website information is the most current.

This Excedrin product contains stearic acid, magnesium stearate, zinc stearate, and pregelatinized corn starch.

On our first call we were told that she had “no information on animal derivatives.” She sent our questions about stearic acid, magnesium stearate, zinc stearate, and pregelatinized corn starch to their medical information team and stated that she would get back to us.

On a second call, we were told that “bovine or porcine gelatin” is used “in all Excedrin products where there is gelatin.” He also relayed that “one or more ingredients in Excedrin may be derived from material of animal origin (beef or pork derivatives).” We asked if this statement were true for all Excedrin products and was told “yes.” He also volunteered that “Glycerin is plant-derived in all GSK products.”

On our third call it was stated that the medical information team had repeated what was said on the second call. There was no new information on the specific ingredients that we had inquired about.

Motrin
We also contacted Johnson & Johnson by phone about its Motrin pain relievers. https://www.motrin.com/products/motrin-ib

Table 1. Motrin Products & Ingredients
Product Ingredients
Motrin IB liquid gels gelatin
Motrin IB caplets magnesium stearate, stearic acid, shellac, pregelatinized starch
Motrin PM caplets magnesium stearate, lactose monohydrate, pregelatinized starch

The VRG first attempted to obtain animal ingredient source information through the Motrin’s website contact request form. We asked if magnesium stearate and stearic acid were derived from animal sources. This is what we received in an email reply:

Regarding Motrin IB caplets, Johnson & Johnson’s Consumer Care Center wrote:

…At this time, we are unable to confirm the absence of the ingredients which you are inquiring about in this product. We make every effort to provide information that is as comprehensive as possible. This is sometimes complicated as the source of an ingredient or mixture(s) used at very low levels in our products may change from time to time. When we are unable to confirm the presence or absence of specific allergens or ingredients right away, this information is provided to our product development department for future consideration.”
Regarding Motrin PM caplets, the Johnson & Johnson Consumer Care Center stated in an email:

“The lactose monohydrate is derived from milk. We also were not able to confirm if there were any other animal-derived ingredients in the caplets.”

In order to gather some more information we then called Johnson & Johnson. We spoke about the Motrin IB caplets. The representative stated that “No animal ingredient or animal byproducts are in this product” but had no specific source information for each ingredient.

However, another representative was able to state the following about the ingredients in the Motrin IB caplets:
•Magnesium stearate is an ink printing agent.
•Stearic acid serves as a lubricant in the product’s coating.
•Shellac is a coating agent.

She had no source information for shellac.

It appears from her general statement (if accurate) given previously about this product being free of animal ingredients that the manufacturer does not consider shellac to be derived from an animal source. We know that shellac is derived from insects. http://www.vrg.org/blog/2010/11/30/q-a-on-shellac/

The representative identified the pregelatinized starch as cornstarch.

We were also told that Motrin PM caplets contain dairy in the form of lactose monohydrate. There is no allergen statement on the package because “due to FDA regulations an allergen statement does not have to be on the package.”

We pursued further and asked if the lack of an allergen statement were possible because of the small quantity of lactose present or the non-requirement of an allergen statement on pharmaceuticals. The rep did not have further information regarding this point.

Target
The Target website did not list label ingredients.
https://www.target.com/p/acetaminophen-tension-headache-coated-caplets-compare-to-excedrin-tension-headache-100ct-up-up-153/-/A-15041896

We found them here:
gel capsules: https://www.drugs.com/otc/117325/tension-headache-relief.html
colloidal silicon dioxide, FD&C blue #1, FD&C red #40, gelatin, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, simethicone, sodium starch glycolate, stearic acid, titanium dioxide

tablets: https://www.drugs.com/otc/121489/tension-headache-relief.html
corn starch, crospovidone, D&C red #27 aluminum lake, FD&C blue #2 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, sodium starch glycolate, stearic acid, talc, titanium dioxide

On our first call, the Target representative stated that he had no list of ingredients and immediately transferred us to his supervisor. She sent my questions to another department for a reply.

After one week we called again for an update and spoke with a Target representative. He checked and said there were not yet any updates and sent me to the Minnesota corporate office customer service department. She again wrote down my questions and said they would get back to me soon.

A few days later, I received an email which stated:
“I was able to get in contact with the manufacturer in regards to your inquiry. They were able to advise that the pregelatinized starch is vegetable-based. Also, the magnesium stearate and stearic acid are plant-based as well.”

As mentioned previously, this product’s formulation differs significantly between the tablet and gel capsule. However, note that the Target brand gel capsules contain both gelatin and pregelatinized starch. Consumers who inquire about this or similar products should emphasize this difference in their email or phone inquiry to avoid being mistakenly told that gelatin’s source information applies to pregelatinized starch as well. (VRG inquirer Theresa had been told this about pregelatinized starch when calling the consumer information line.)

Possibly Animal-Derived Ingredients in Pain Relievers
Vegans and vegetarians should be aware that other ingredients in common pain killers may be animal-derived.

Gelatin is common in capsule forms. Insect-derived shellac was listed in some pain relievers such as Motrin IB caplets.
https://www.motrin.com/products/motrin-ib

Other common ingredients that could be animal-derived include
•stearic acid
•magnesium stearate
•zinc stearate
•lactose monohydrate

The contents of this posting, our website and our other publications, including Vegetarian Journal, are not intended to provide personal medical advice. Medical advice should be obtained from a qualified health professional. We often depend on product and ingredient information from company statements. It is impossible to be 100% sure about a statement, info can change, people have different views, and mistakes can be made. Please use your best judgment about whether a product is suitable for you. To be sure, do further research or confirmation on your own.

To support this type of detailed research, please consider donating to The Vegetarian Resource Group here: https://www.givedirect.org/donate/?cid=1565