Daytime Severe Cold and Flu
- Dosage form
- TABLET, FILM COATED
- Labeler
- Spirit Pharmaceuticals LLC
- Label updated
- 2024-12-30
- Retrieved
- 2026-09-07
- Active ingredients
- ACETAMINOPHEN · DEXTROMETHORPHAN HYDROBROMIDE · GUAIFENESIN
Drug Facts
Active ingredients (in each caplet)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5
Purpose
Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant
Uses
• for the temporary relief of the following cold/flu symptoms: • minor aches and pains
• headache • sore throat • nasal congestion • cough • helps loosen phlegm (mucus) and thin
bronchial secretions to make coughs more productive • temporarily reduces fever
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
• liver disease • heart disease • high blood pressure • thyroid disease • diabetes • trouble urinating due to an enlarged prostate gland • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema • cough that occurs with too much phlegm (mucus)
Ask a doctor or pharmacist before use
if you are taking the blood thinning drug warfarin
When using this product do not exceed recommended dosage
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,
ask a health professional before use.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
do not take more than directed
| adults and children 12 years & over | • take 2 caplets every 4 hours • swallow whole; do not crush, chew or dissolve • do not take more than 10 caplets in 24 hours |
| children under 12 years | ask a doctor |
Other information
store at 25ºC (77ºF); excursions permitted between 15º–30ºC (59º–86ºF)
Inactive Ingredients
croscarmellose sodium, D&C Yellow#10, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone*, pregelatinized starch, talc, titanium dioxide *may contain this ingredient
Questions or comments?
1-888-333-9792
Distributed by:
Cabinet Health P.B.C.
Principal Display panel
[Image in the official label — see DailyMed source]
[Image in the official label — see DailyMed source]
DailyMed Set ID: f93b4f1f-ce3d-4c2b-92be-5d1e29990b73 · Version 8
NDC: 68210-4221