Label: ACETAMINOPHEN 325MG, DEXTROMETHORPHAN HBR 10MG AND PHENYLEPRINE HCL 5MG- acetaminophen, dextromethorphan hbr and phenylephrine hcl capsule, liquid filled
- NDC Code(s): 35916-0188-1, 35916-0188-2
- Packager: Softgel Healthcare Private Limited
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated June 8, 2025
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 softgelatin capsule)
- Purposes
- Uses
-
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 productAllergy alert: Acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include:
• skin reddening • blisters • rash • hives
• facial swelling • asthma (wheezing) • shockIf a skin or general allergic reaction occurs, stop use and seek medical help right away
Sore 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
● with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
● 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.
● if you have ever had an allergic reaction to this product or any of its ingredients
● in children under 12 years of age
- Ask a doctor before use if you have
- Ask a doctor or pharmacist before use if you are
- WHEN USING
-
Stop use and ask a doctor if
- pain, cough, or nasal congestion gets worse or lasts more than 7 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- cough comes back or occurs with rash or headache that lasts.
These could be signs of a serious condition.
- nervousness, dizziness, or sleeplessness occurs
- If pregnant or breast-feeding,
- Keep out of reach of children
- Directions
- Other information
- Inactive ingredients
- BULK PACKAGE LABEL
-
INGREDIENTS AND APPEARANCE
ACETAMINOPHEN 325MG, DEXTROMETHORPHAN HBR 10MG AND PHENYLEPRINE HCL 5MG
acetaminophen, dextromethorphan hbr and phenylephrine hcl capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:35916-0188 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg Inactive Ingredients Ingredient Name Strength FD&C YELLOW NO. 6 (UNII: H77VEI93A8) WATER (UNII: 059QF0KO0R) SORBITAN (UNII: 6O92ICV9RU) MICA (UNII: V8A1AW0880) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) GLYCERIN (UNII: PDC6A3C0OX) SORBITOL (UNII: 506T60A25R) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POVIDONE K30 (UNII: U725QWY32X) GELATIN (UNII: 2G86QN327L) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Product Characteristics Color orange (Glitter) Score no score Shape OVAL Size 16mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:35916-0188-1 1000 in 1 BAG; Type 0: Not a Combination Product 03/21/2025 2 NDC:35916-0188-2 2 in 1 BOX 06/12/2025 2 3000 in 1 POUCH; 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 03/21/2025 Labeler - Softgel Healthcare Private Limited (675584180)