Label: ALLERGY DYEFREE capsule, liquid filled
- NDC Code(s): 69168-409-86
- Packager: Allegiant Health
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated April 26, 2021
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- Official Label (Printer Friendly)
- Active ingredient(s)
- Purpose
- Use(s)
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Warnings
Do not use
- to make a child sleepy
- with any other product containing diphenhydramine, even one used on skin
Ask a doctor before use if
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- trouble urinating due to an enlarged prostate gland
- Directions
- Other information
- Storage
- Inactive ingredients
- Questions
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
ALLERGY DYEFREE
allergy dyefree capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69168-409 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg Inactive Ingredients Ingredient Name Strength GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) WATER (UNII: 059QF0KO0R) SORBITOL SOLUTION (UNII: 8KW3E207O2) Product Characteristics Color yellow (Clear) Score no score Shape CAPSULE Size 15mm Flavor Imprint Code PC4 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69168-409-86 12 in 1 BLISTER PACK; Type 0: Not a Combination Product 04/27/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part336 09/15/2013 Labeler - Allegiant Health (079501930)