Label: NIGHTTIME SLEEP AID- diphenhydramine hcl 25 mg tablet, coated
- NDC Code(s): 71679-110-03, 71679-110-06, 71679-110-10
- Packager: Health Pharma USA LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated October 20, 2023
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- Official Label (Printer Friendly)
- Active ingredient (in each caplet)
- Purpose
- Uses
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Warnings
Do not use
- for children under 12 years of age
- with any other product containing diphenhydramine, even one used on skin
- with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products
Ask a doctor before use if you have
- a breathing problem such as asthma, emphysema or chronic bronchitis
- glaucoma
- trouble urinating due to an enlarged prostate gland
-
heart disease
Ask your doctor or pharmacist before use if you are
- taking sedative or tranquilizers or any other sleep-aid
When using this product
- drowsiness will occur
- avoid alcoholic beverages and other drugs that cause drowsiness
- excitability may occur, especially in children
- alcohol, sedatives and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
Stop use and ask a doctor if
sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
Keep out of reach of children.
Overdose warning:Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
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INGREDIENTS AND APPEARANCE
NIGHTTIME SLEEP AID
diphenhydramine hcl 25 mg tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71679-110 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 ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) STEARIC ACID (UNII: 4ELV7Z65AP) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color blue Score no score Shape CAPSULE Size 11mm Flavor Imprint Code S25 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71679-110-03 300 in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2022 2 NDC:71679-110-06 600 in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2022 3 NDC:71679-110-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M010 01/01/2022 Labeler - Health Pharma USA LLC (080804485) Establishment Name Address ID/FEI Business Operations Health Pharma USA LLC 080804485 manufacture(71679-110)