Label: PAIN RELIEF PM- acetaminophen, diphenhydramine tablet
- NDC Code(s): 72090-006-25
- Packager: Pioneer Life Sciences, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated May 8, 2024
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- Official Label (Printer Friendly)
- Active Ingredients (in each caplet)
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Purpose
Acetaminophen 500 mg ....................................................................................................................................Pain reliever
Diphenhydramine HCl 25 mg ...........................................................................….................................Nighttime sleep aid - Uses:
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Warnings:
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take ■ more than 4,000 mg of acetaminophen in 24 hrs ■ 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
■ 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
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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
- Directions:
- Other Information:
- Inactive Ingredients:
- Questions or Comments?
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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PAIN RELIEF PM
acetaminophen, diphenhydramine tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72090-006 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 FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) Magnesium Stearate (UNII: 70097M6I30) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) STARCH, CORN (UNII: O8232NY3SJ) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) STEARIC ACID (UNII: 4ELV7Z65AP) Titanium Dioxide (UNII: 15FIX9V2JP) Product Characteristics Color blue Score no score Shape CAPSULE Size 27mm Flavor Imprint Code None Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72090-006-25 375 in 1 BOTTLE; Type 0: Not a Combination Product 05/08/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 05/08/2024 Labeler - Pioneer Life Sciences, LLC (014092742) Registrant - Pioneer Life Sciences, LLC (014092742)