Label: ACETAMINOPHEN DIPHENHYDRAMINE HCL tablet
- NDC Code(s): 0363-9664-60
- Packager: WALGREENS CO.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 March 1, 2022
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- Official Label (Printer Friendly)
- Active ingredients (in each gelcap)
- 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
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Inactive ingredients
colloidal silicon dioxide, croscarmellose sodium, D&C red#28, D&C yellow#10, FD&C 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.
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INGREDIENTS AND APPEARANCE
ACETAMINOPHEN DIPHENHYDRAMINE HCL
acetaminophen diphenhydramine hcl tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-9664 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 HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K) STARCH, CORN (UNII: O8232NY3SJ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) STEARIC ACID (UNII: 4ELV7Z65AP) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C RED NO. 40 (UNII: WZB9127XOA) GELATIN (UNII: 2G86QN327L) ISOPROPYL ALCOHOL (UNII: ND2M416302) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) BUTYL ALCOHOL (UNII: 8PJ61P6TS3) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) D&C RED NO. 28 (UNII: 767IP0Y5NH) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) POVIDONE (UNII: FZ989GH94E) SHELLAC (UNII: 46N107B71O) TRIACETIN (UNII: XHX3C3X673) Product Characteristics Color 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 G3 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-9664-60 125 in 1 BOTTLE; Type 0: Not a Combination Product 09/30/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 09/30/2022 Labeler - WALGREENS CO. (008965063)