Label: ACETAMINOPHEN, DEXTROMETHORPHAN HBR capsule, liquid filled
- NDC Code(s): 84324-036-01
- Packager: NUVICARE LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated August 6, 2026
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 softgel)
- Purpose
- Uses
-
Warnings
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.Liver warning
This product contains acetaminophen. Severe liver damage may occur if you take:
• More than 8 softgels in 24 hours, which is the maximum daily amount for this product
• With other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this productSore throat warning
If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. - DO NOT USE
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ASK DOCTOR/PHARMACIST
Ask a doctor before use if you are
• Now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug.
• If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. - ASK DOCTOR
- WHEN USING
- ASK DOCTOR/PHARMACIST
-
STOP USE
Stop use and ask a doctor if
• Pain, cough, or nasal congestion gets worse or lasts more than 7 days.
• New symptoms occur.
• Nervousness, dizziness, or sleeplessness occur.
• Fever gets worse or lasts more than 3 days.
• Redness or swelling is present.
• Cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition. - PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- OVERDOSAGE
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- NDC 84324-036-01
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INGREDIENTS AND APPEARANCE
ACETAMINOPHEN, DEXTROMETHORPHAN HBR
acetaminophen, dextromethorphan hbr capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:84324-036 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg Inactive Ingredients Ingredient Name Strength POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) Propylene Glycol (UNII: 6DC9Q167V3) POVIDONE (UNII: FZ989GH94E) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) WATER (UNII: 059QF0KO0R) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) SORBITAN (UNII: 6O92ICV9RU) Product Characteristics Color red Score no score Shape OVAL (Oblong) Size 17mm Flavor Imprint Code BZ10 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:84324-036-01 1 in 1 CARTON 06/17/2026 1 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 06/17/2026 Labeler - NUVICARE LLC (119257565)

