Label: DAYTIME SEVERE COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride tablet, film coated
- NDC Code(s): 68210-4231-3
- Packager: Spirit Pharmaceuticals LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 13, 2024
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients (in each caplet)
- Purpose
- Uses
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Warnings
Liver warning: This product contains acetaminophen. The maximum daily dose of this product is
10 caplets (3,250 mg acetaminophen) in 24 hours. 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.
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. - Ask a doctor before use if you have
- Ask a doctor or pharmacist before use
- When using this product do not exceed recommended dosage
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Stop use and ask a doctor if
• nervousness, dizziness, or sleeplessness occur • pain, nasal congestion or cough 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.
- If pregnant or breast-feeding,
- Keep out of reach of children.
- Directions
- Other information
- Inactive Ingredients
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INGREDIENTS AND APPEARANCE
DAYTIME SEVERE COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68210-4231 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 GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE 5 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) POVIDONE (UNII: FZ989GH94E) STARCH, POTATO (UNII: 8I089SAH3T) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color yellow Score no score Shape CAPSULE Size 20mm Flavor Imprint Code ET32 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68210-4231-3 30 in 1 POUCH; Type 0: Not a Combination Product 11/16/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 11/16/2022 Labeler - Spirit Pharmaceuticals LLC (179621011)