Label: ALLERGY RELIEF- diphenhydramine hydrochloride tablet, film coated
- NDC Code(s): 70677-1238-1
- Packager: Strategic Sourcing Services, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 25, 2024
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient (in each tablet) Diphenhydramine HCl 25 mg
- Purpose Antihistamine
- Uses • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose • itchy, watery eyes • sneezing • itching of the nose or throat • temporarily relieves these symptoms due to the common cold: • runny nose • sneezing
- 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 • trouble urinating due to an enlarged prostate gland • glaucoma
- Ask a doctor or pharmacist before use if you aretaking sedatives or tranquilizers
- When using this product• marked drowsiness may occur • avoid alcoholic drinks • alcohol, sedatives and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinery • excitability may occur, especially in children
- If pregnant or breast-feeding,ask a health professional before use.
- Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
- Directions• take every 4 to 6 hours, or as directed by a doctor • do not take more than 6 doses in 24 hours • adults and children 12 years of age and over - 1 to 2 tablets • children 6 to under 12 years of age - 1 tablet • children under 6 years of age - do not use
- Other information• each tablet containscalcium 24 mg • store between 20°-25° C (68°-77° F). • Protect from light
- Inactive ingredients c olloidal silicon dioxide, croscarmellose sodium, dicalcium phosphate, D&C red # 27 aluminium lake, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide
- Questions or comments? 1-833-358-6431
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INGREDIENTS AND APPEARANCE
ALLERGY RELIEF
diphenhydramine hydrochloride tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70677-1238 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 SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J) D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color pink Score no score Shape OVAL Size 11mm Flavor Imprint Code S4 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70677-1238-1 120 in 1 BOTTLE; Type 0: Not a Combination Product 01/24/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 01/24/2024 Labeler - Strategic Sourcing Services, LLC (116956644)
