Label: ACETAMINOPHEN DIPHENHYDRAMINE HCL tablet
- NDC Code(s): 0363-9799-75
- Packager: WALGREEN CO.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 16, 2024
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Acetaminophen Gelcaps Active Ingredient (in each Gelcap)
- Purpose
- Uses
- Liver Warning
- Allergy Alert
- Do not use
- Ask a doctor before use if you have
- Ask a doctor or pharmacist before use if you are
- Stop use and ask doctor if
- If pregnant or breast-feeding
- Keep out of the reach of children.
- Overdose Warning
-
Directions
■ do not take more than directed (see overdose warning)
adults and children 12 years and over
■ take 2 gelcaps every 6 hours while symptoms last
■ do not take more than 6 gelcaps in 24 hours, unless directed by a doctor
■ do not take more than 10 days unless directed by a doctor
children under 12 years
■ ask a doctor
- Other information
-
Inactive ingredients
ammonium hydroxide, black iron oxide, colloidal silicon dioxide, croscarmellose sodium, D&C red#33, FD&C blue#1, FD&C red#40, FD&C yellow#6, gelatin, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, hypromellose, iron oxide red, isopropyl alcohol, n-butyl alcohol, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, stearic acid, titanium dioxide, yellow iron oxide.
- Questions or comments?
- Acetaminophen PM Gelcaps Active ingredient (in each gelcap)
- Purposes
- Uses
- Liver warning
- Allergy alert
-
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 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 the reach of children.
- Overdose warning
- Directions
- Other information
-
Inactive ingredients
colloidal silicon dioxide, croscarmellose sodium, D7C red#28, D&C yellow#10, FD7C blue#1, FD&C blue #2, FD&C red #40, FD&C yellow #6, gelatin, hydroxypropyl cellulose, hypromellose, isopropyl alcohol, microcrystalline cellulose, n-butyl alcohol, povidone, pregelatinized starch, propylene glycol, shellac glaze, stearic acid, titanium dioxide, triacetin.
- Questions or comments?
- Principal Display Panel
-
INGREDIENTS AND APPEARANCE
ACETAMINOPHEN DIPHENHYDRAMINE HCL
acetaminophen diphenhydramine hcl tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-9799 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg Inactive Ingredients Ingredient Name Strength TRIACETIN (UNII: XHX3C3X673) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) D&C RED NO. 28 (UNII: 767IP0Y5NH) GELATIN (UNII: 2G86QN327L) BUTYL ALCOHOL (UNII: 8PJ61P6TS3) SHELLAC (UNII: 46N107B71O) STEARIC ACID (UNII: 4ELV7Z65AP) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) AMMONIA (UNII: 5138Q19F1X) FD&C RED NO. 40 (UNII: WZB9127XOA) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) FERRIC OXIDE RED (UNII: 1K09F3G675) STARCH, CORN (UNII: O8232NY3SJ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERROSOFERRIC OXIDE (UNII: XM0M87F357) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) ISOPROPYL ALCOHOL (UNII: ND2M416302) POVIDONE (UNII: FZ989GH94E) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) Product Characteristics Color gray (Encapsulated gray color tablets with one red opaque and one blue-gray opaque hard gelatin shells) , gray (Encapsulated gray color tablets with dark blue opaque and light blue opaque hard gelatin shells) Score no score Shape OVAL Size 20mm Flavor Imprint Code G1;G3 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-9799-75 75 in 1 BOTTLE; Type 1: Convenience Kit of Co-Package 03/03/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 03/03/2023 Labeler - WALGREEN CO. (008965063)