Label: ALLERGY RELIEF- diphenhydramine hcl tablet
- NDC Code(s): 21130-329-06, 21130-329-08, 21130-329-12, 21130-329-22
- Packager: Better Living Brands, LLC
- 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 August 18, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- Uses
-
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 you have
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- difficulty in urination due to enlargement of the prostate gland
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
-
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Compare to Benadryl®
Allergy ULTRATAB® Tablets
active ingredient**NDC 21130-329-06
Allergy Relief
Diphenhydramine HCl 25 mg
Antihistamine• Relief of:
Sneezing, runny nose, itchy
throat & itchy, watery eyesActual Size
200 MINITABS
TAMPER EVIDENT: DO NOT USE IF
IMPRINTED SAFETY SEAL UNDER
CAP IS BROKEN OR MISSING**This product is not manufactured or distributed
by Johnson & Johnson Corporation, distributors of
Benadryl® Allergy ULTRATAB® Tablets.
50844 REV0721E32906DISTRIBUTED BY
BETTER LIVING BRANDS LLC
P.O. BOX 99, PLEASANTON, CA 94566-0009
1-888-723-3929
www.betterlivingbrandsLLC.comOUR PROMISE
QUALITY & SATISFACTION
100% GUARANTEED
OR YOUR MONEY BACK.Signature Care 44-329
-
INGREDIENTS AND APPEARANCE
ALLERGY RELIEF
diphenhydramine hcl tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:21130-329 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 STARCH, CORN (UNII: O8232NY3SJ) D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX) DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color pink Score no score Shape OVAL Size 11mm Flavor Imprint Code 44;329 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:21130-329-12 1 in 1 CARTON 03/02/1990 1 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:21130-329-22 4 in 1 CARTON 03/02/1990 2 12 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:21130-329-06 1 in 1 CARTON 03/02/1990 3 200 in 1 BOTTLE; Type 0: Not a Combination Product 4 NDC:21130-329-08 2 in 1 CARTON 03/02/1990 4 12 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 03/02/1990 Labeler - Better Living Brands, LLC (009137209) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 manufacture(21130-329) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 pack(21130-329) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 manufacture(21130-329) , pack(21130-329) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 pack(21130-329) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 pack(21130-329)