Label: EXTRA STRENGTH NITETIME PAIN RELIEF- acetaminophen 500 mg,diphenhydramine hydrochloride 25 mg tablet tablet
- NDC Code(s): 0363-0714-42
- Packager: WALGREENS
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated January 30, 2025
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- Official Label (Printer Friendly)
- DRUG FACTS
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take- more than 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
If a skin reaction occurs, stop use and seek medical help right away.
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DO NOT USE
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 DOCTOR
- ASK DOCTOR/PHARMACIST
- WHEN USING
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STOP USE
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.
- 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.
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- SPL UNCLASSIFIED SECTION
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
EXTRA STRENGTH NITETIME PAIN RELIEF
acetaminophen 500 mg,diphenhydramine hydrochloride 25 mg tablet tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0714 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 ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg Inactive Ingredients Ingredient Name Strength STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) STARCH, CORN (UNII: O8232NY3SJ) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) POVIDONE (UNII: FZ989GH94E) TALC (UNII: 7SEV7J4R1U) CARNAUBA WAX (UNII: R12CBM0EIZ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) Product Characteristics Color blue Score no score Shape CAPSULE Size 20mm Flavor Imprint Code TCL430 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-0714-42 1 in 1 CARTON 10/12/2021 1 24 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 10/12/2021 Labeler - WALGREENS (008965063) Registrant - TIME CAP LABORATORIES, INC. (037052099) Establishment Name Address ID/FEI Business Operations TIME CAP LABORATORIES, INC. 037052099 manufacture(0363-0714)