Label: ALLERGY RELIEF- diphenhydramine hydrochloride capsule, liquid filled
- NDC Code(s): 70692-780-16
- Packager: Strive Pharmaceuticals Inc.
- 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 13, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient (in each softgel)
- Purpose
- Uses
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Warnings
Do not use
• to make a child sleepy
• with any other product containing diphenhydramine, even one used on skinAsk a doctor before use if you have
• a breathing problem such as emphysema or chronic bronchitis
• glaucoma
• difficulty in urination due to enlargement to the prostate glandAsk a doctor or pharmacist before use if you are taking sedatives or tranquilizers.
When using this product
• marked drowsiness may occur
• avoid alcoholic beverages
• alcohol, sedatives, and tranquilizers may increase drowsiness
• use caution when driving a motor vehicle or operating machinery
• excitability may occur, especially in childrenIf pregnant or breast-feeding, ask a health professional before use.
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
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SPL UNCLASSIFIED SECTION
Compare to the active ingredient in Benadryl® Dye-Free Allergy*
RIGHT REMEDIES
READ AND KEEP OUTER PACKAGE FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS SIGNS OF TAMPERING
*This product is not manufactured or distributed by Johnson&Johnson Corporation, owner of the registered trademark Benadryl® Dye-Free Allergy.
Distributed by: Strive Pharmaceuticals Inc., East Brunswick, NJ 08816
Product of United Arab Emirates
Packaged and Quality Assured in the USAREV.00-022022
- Packaging
-
INGREDIENTS AND APPEARANCE
ALLERGY RELIEF
diphenhydramine hydrochloride capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70692-780 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, UNSPECIFIED (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) ISOPROPYL ALCOHOL (UNII: ND2M416302) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) SORBITAN (UNII: 6O92ICV9RU) Product Characteristics Color white (Transparent) Score no score Shape OVAL (oblong) Size 15mm Flavor Imprint Code 780 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70692-780-16 2 in 1 CARTON 04/06/2023 1 8 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 04/06/2023 Labeler - Strive Pharmaceuticals Inc. (080028013)