Monday, June 6, 2016

Gluten-free acetaminophen (Children's Tylenol)

Note:  I am not a doctor or pharmacist, nor do I work for Johnson & Johnson.  The following is only my opinion, use at your own risk.


I have been going crazy trying to determine if the Children's Tylenol Suspension I have been given my daughter is gluten-free or not.

The short answer is YES, I think so.  However, Johnson & Johnson does not certify Tylenol as gluten-free, so there is a risk of cross-contamination.

The following Children's Tylenol Suspension products in Canada should be GF:
  • Grape
  • Grape Punch
  • Banana Berry
  • Banana Berry Twist
  • Dye-free Berry
  • Cherry
  • Bubble Gum
  • Bubble Gum Burst 
 Tedious explanation of how I figured this out below.  It ONLY applies to Children's Tylenol Suspensions - I did not look at tablets or infant formulations.


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The product in question was Children's Tylenol Suspension, "Berry" flavor.  Circa 2016.

Tylenol used to publish a GF list.  However, this list was retracted, so all of the information out there is out of date.  Some dates to 2003, which is a long time for a product to NOT change.

This historical list stated that the "Grape" flavor was gluten-free.  Ours was "Berry, Dye-Free" flavor.  Tylenol Canada listed Berry, Banana Berry, Grape, Cherry, and Bubble Gum flavors, but there are others available such as "Cherry Blast", "Banana Berry Twist", and "Grape Punch".  Are these different?  Who knows?


Tylenol USA showed only "Cherry Blast" and "Grape".  But we probably all know by now that there are several known cases where USA products differ from their identically-named Canadian versions.  So when you get a Canadian product that has a single word different in the name, is it the same or not?

Of course, I couldn't readily find the original "Grape" flavor.  And I didn't know if the two bottles of "Berry" are OK to use or not.


Here's how I worked it out:

First, I compared the Costco "gluten-free" Grape Punch ingredients list with the official Johnson & Johnson Grape formulation for Canada.  They are identical.  So Grape = Grape Punch.

Next, I looked at their ingredients.  Nothing screams "gluten" in them, except for the generic "flavor". 

So, since Costco claims "Grape Punch" is gluten-free, and it was identical to J&J "Grape" which was gluten-free, both are likely gluten free.  So for the purposes of discussion I'm assuming the Grape / Grape Punch flavors are GF.



I then compared the ingredients of Canadian "Grape" and all the other flavors (see official page here).  Since "Grape" is GF, any ingredients in "Grape" are safe, so I discounted them.  This left the following unique ingredients in the other flavors:

-  FD&C red no.40
-  sodium citrate
-  sucralose
-  sucrose

None of these inherently have gluten.  So leaving cross-contamination / shared line issues aside, none should make the Tylenol non-GF.


Finally, I looked at the other flavors:
-  Grape = Grape Punch
-  Banana Berry = Banana Berry Twist
-  Bubble Gum = Bubble Gum Burst


From this, and barring cross-contamination issues, the following Children's Tylenol Suspension products in Canada should be GF:

  • Grape / Grape Punch
  • Banana Berry / Banana Berry Twist
  • Dye-free Berry
  • Cherry
  • Bubble Gum / Bubble Gum Burst 
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Here is the original Costco (Canada) information on these products.  I have reproduced it here in case it disappears; original page is here.

According to Costco (Canada), the following Tylenol products are gluten-free.  I doubt this is certified in any way, and I further doubt Johnson & Johnson is actually going to stand by this claim.  At best, I expect they will state they are not using any gluten-containing ingredients, but will not stipulate no shared lines or equipment.  

Similarly, I have not found any reports of kids getting "glutened" from taking Tylenol products.  So take this for whatever this is worth.

From Costco:

According to Costco (Canada), all of the items below are gluten-free:

Caplets
Regular Strength 325 mg
Each elongated, capsule-shaped white tablet, engraved "TYLENOL" on one side and "325" on the other side, contains acetaminophen 325 mg. Nonmedicinal ingredients: cellulose, cornstarch, hypromellose, magnesium stearate, polyethylene glycol, and sodium starch glycolate. Gluten-, lactose-, and tartrazine-free.

Extra Strength 500 mg
Each elongated, capsule-shaped white tablet, engraved "TYLENOL" on one side and "500" on the other side, contains acetaminophen 500 mg. Nonmedicinal ingredients: cellulose, cornstarch, hypromellose, magnesium stearate, polyethylene glycol, and sodium starch glycolate. Gluten-, lactose-, and tartrazine-free.

Gelcaps

Extra Strength 500 mg ("Rapid Release")
Each solid, capsule-shaped tablet, coated with red gelatin on one end, blue gelatin on the other end, a gray band between the two gelatin-coated ends, printed "TY" on one gelatin-coated end and "500" on the other gelatin-coated end, contains acetaminophen 500 mg. Nonmedicinal ingredients: butylparaben, carboxymethylcellulose sodium, cellulose, corn starch, FD&C Yellow No. 10, edetate calcium disodium, FD&C Blue No. 1, FD&C Red No. 40, gelatin, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, methylparaben, polyethylene glycol, polysorbate 80, propylparaben, sodium lauryl sulfate, sodium propionate, sodium starch glycolate, and titanium dioxide. Gluten-, lactose-, and tartrazine-free.

Extended Release

ARTHRITIS PAIN 650 mg
Each elongated, white extended release tablet, engraved "TYLENOL ER" on one side, contains acetaminophen 650 mg (325 mg immediate release acetaminophen and 325 mg delayed release acetaminophen in a slow dissolving matrix). Nonmedicinal ingredients: carnauba wax, cellulose, cornstarch, hydroxyethyl cellulose, hypromellose, magnesium stearate, povidone, sodium starch glycolate, titanium dioxide, and triacetin. Gluten-, lactose-, and tartrazine-free.

Muscle Aches & Body Pain
Each elongated, white extended release tablet, engraved ''TYLENOL ER'' on one side, contains acetaminophen 650 mg (325 mg immediate release acetaminophen and 325 mg delayed release acetaminophen in a slow dissolving matrix). Nonmedicinal ingredients: carnauba wax, cellulose, cornstarch, hydroxyethyl cellulose, hypromellose, magnesium stearate, povidone, sodium starch glycolate, titanium dioxide, and triacetin. Gluten-, lactose-, and tartrazine-free.

Tablets

Regular Strength 325 mg
Each round, white tablet, engraved "TYLENOL" one side and "325" the other side, contains acetaminophen 325 mg. Nonmedicinal ingredients: cellulose, cornstarch, magnesium stearate, and sodium starch glycolate. Gluten-, lactose-, and tartrazine-free.

Extra Strength 500 mg ("eZ TABS")
Each round, red, sweet-coated tablet, printed with "TYLENOL 500", contains acetaminophen 500 mg. Nonmedicinal ingredients: carnauba wax, cellulose, cornstarch, FD&C Red No. 40, FD&C Yellow No. 6, hypromellose, iron oxide black, polyethylene glycol, polysorbate 80, povidone, sodium starch glycolate, stearic acid, sucralose, and titanium dioxide. Gluten-, lactose-, and tartrazine-free.

Children

Tablets

Children's Tylenol
This medication is available as a 80 mg tablet.

Junior Strength 160 mg
This medication is available as a 160 mg tablet.

Junior Strength Fastmelts 160 mg
This medication is available as a 160 mg tablet.

Bubblegum Burst Flavour
Each pink, 5/8" round troche tablet with characteristic bubblegum odour, debossed with "TY" over "160" on one side, contains acetaminophen 160 mg. Nonmedicinal ingredients: cellulose acetate, citric acid, FD&C Red No. 7, dextrose, flavour, magnesium stearate, povidone, and sucralose. Gluten-, lactose-, and tartrazine-free.

Grape Punch Flavour
Each purple, 5/8" round troche tablet with characteristic grape odour, debossed with "TY" over "160" on one side, contains acetaminophen 160 mg. Nonmedicinal ingredients: cellulose acetate, citric acid, FD&C Red No. 7, FD&C Red No. 30, dextrose, FD&C Blue No. 1, flavour, magnesium stearate, povidone, and sucralose. Gluten-, lactose-, and tartrazine-free.

Suspension




Note:  Per the analysis given at the top of this post, all of these suspensions are naturally GF, as are .  J&J does not certify as such, so cross-contamination is still a potential issue.

Children's 160 mg/5 mL (Banana Berry Twist)
Each 5 mL contains acetaminophen 160 mg in a pink liquid vehicle with a strawberry-banana flavoured taste. Nonmedicinal ingredients: butylparaben, carboxymethylcellulose sodium, cellulose, citric acid, corn syrup, FD&C Red No. 40, flavour, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol, and xanthan gum. Gluten-, lactose-, and tartrazine-free.

Children's 160 mg/5 mL (Bubblegum Burst)
Each 5 mL contains acetaminophen 160 mg in a dark pink liquid vehicle with a bubble gum-flavoured taste. Nonmedicinal ingredients: butylparaben, carboxymethylcellulose sodium, cellulose, citric acid, corn syrup, FD&C Red No. 33, FD&C Red No. 40, flavour, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol, and xanthan gum. Gluten-, lactose-, and tartrazine-free.

Children's 160 mg/5 mL (Grape Punch)
Each 5 mL contains acetaminophen 160 mg in a purple liquid vehicle with a grape-flavoured taste. Nonmedicinal ingredients: butylparaben, carboxymethylcellulose sodium, cellulose, citric acid, corn syrup, FD&C Red No. 33, FD&C Blue No. 1, flavour, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol, and xanthan gum. Gluten-, lactose-, and tartrazine-free.

[Note: the USA versions have different non-medicinal ingredients, so the Canadian and USA versions should not be considered identical.  See the USA versions of Children's Tylenol here.]

Suspension Drops

Infants' 80 mg/mL (Cherry)
Each mL contains acetaminophen 80 mg in a red liquid vehicle with a cherry-flavoured taste. Nonmedicinal ingredients: butylparaben, carboxymethylcellulose sodium, cellulose, citric acid, corn syrup, FD&C Red No. 40, flavour, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol, and xanthan gum. Gluten-, lactose-, and tartrazine-free.

Infants' 80mg/mL (Dye Free White Grape)
Each mL contains acetaminophen 80 mg in a white to off-white liquid vehicle with a grape-flavoured taste. Nonmedicinal ingredients: butylparaben, carboxymethylcellulose sodium, cellulose, citric acid, corn syrup, flavour, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol, and xanthan gum. Gluten-, lactose-, and tartrazine-free.




1 comment:

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