Label: ALLERGY RELIEF- diphenhydramine hcl tablet
- NDC Code(s): 55319-329-22
- Packager: Family Dollar Services 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 September 21, 2020
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- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- 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 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?
-
Principal Display Panel
FAMILY
wellness™COMPARE TO THE ACTIVE INGREDIENT IN
BENADRYL® ALLERGY ULTRATAB® TABLETS*Allergy Relief
Diphenhydramine HCl 25 mg
AntihistamineFor Relief of:
• Runny Nose • Itchy Throat
• Sneezing • Itchy, Watery Eyes48 COATED MINITABS
(SMALL SIZE TABLETS)ACTUAL SIZE
OTC
networkTAMPER EVIDENT: DO NOT USE IF
PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS
ANY SIGNS OF TAMPERINGDISTRIBUTED BY: MIDWOOD BRANDS, LLC
10611 MONROE ROAD., MATTHEWS, NC 28105
NOT 100% SATISFIED?
Return package and unused product within 30 days to any
Family Dollar store for a refund (with receipt) or exchange.*This product is not manufactured or distributed by
Johnson & Johnson Corporation, owner of the registered
trademark Benadryl® Allergy ULTRATAB® Tablets.50844 REV1016E32922
Family Wellness 44-329
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INGREDIENTS AND APPEARANCE
ALLERGY RELIEF
diphenhydramine hcl tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55319-329 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 MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX) MAGNESIUM STEARATE (UNII: 70097M6I30) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) STARCH, CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U) ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) 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:55319-329-22 4 in 1 CARTON 03/02/1990 1 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 - Family Dollar Services Inc (024472631) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 MANUFACTURE(55319-329) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 PACK(55319-329) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 MANUFACTURE(55319-329) , PACK(55319-329) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 PACK(55319-329) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 PACK(55319-329)