Label: ACETAMINOPHEN DIPHENHYDRAMINE HCL tablet
- NDC Code(s): 0363-9661-15, 0363-9661-25
- Packager: Walgreens
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated July 23, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients (in each caplet)
- Purposes
- Uses
- Liver warning
- Allergy alert:
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Do not use
■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains
acetaminophen, ask a doctor or pharmacist.
■ with any other product containing diphenhydramine, even one used on skin
■ in children under 12 years of age
■ if you have ever had an allergic reaction to this product or any of its ingredients - Ask a doctor before use if you have
- Ask a doctor or pharmacist before use if you are
- When using this product
-
Stop use and ask a doctor if
■ sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
■ pain gets worse or lasts more than 10 days
■ fever gets worse or lasts more than 3 days
■ redness or swelling is present
■ new symptoms occur
These could be signs of a serious condition - If pregnant or breast-feeding,
- Keep out of reach of children
- Overdose warning
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- Principal Display panel
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INGREDIENTS AND APPEARANCE
ACETAMINOPHEN DIPHENHYDRAMINE HCL
acetaminophen diphenhydramine hcl tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-9661 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg DIPHENHYDRAMINE (UNII: 8GTS82S83M) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE 25 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) STEARIC ACID (UNII: 4ELV7Z65AP) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) STARCH, CORN (UNII: O8232NY3SJ) POVIDONE K30 (UNII: U725QWY32X) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) HYPROMELLOSES (UNII: 3NXW29V3WO) POLYSORBATE 80 (UNII: 6OZP39ZG8H) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CARNAUBA WAX (UNII: R12CBM0EIZ) Product Characteristics Color blue Score no score Shape OVAL (caplet-shaped) Size 17mm Flavor Imprint Code G651 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-9661-15 150 in 1 BOTTLE; Type 0: Not a Combination Product 07/23/2024 2 NDC:0363-9661-25 250 in 1 BOTTLE; Type 0: Not a Combination Product 07/23/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 06/23/2024 Labeler - Walgreens (008965063)