Drug Facts
Drug Facts
The following Structured Product Label (SPL) was submitted to the FDA by Acme United for the product Physicians Care Non-drowsy Cold And Cough (NDC 0924-0142). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, active ingredient, purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
Active ingredient (in each caplet)
Acetaminophen 325 mg
Dextromethorphan Hydrobromide 10 mg
Guaifenesin 100 mg
Phenylephrine Hydrochloride 5 mg
Purpose
Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant
Uses
Temporarily relieves these cold symptoms
Temporarily reduces fever.
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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
Ask a doctor before use if you have
Ask a doctor or pharmacist before use if you are
When using this product do not exceed recommended dosage.
Stop use and ask a doctor if
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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
Adults and children: (12 years and older)
Take 2 caplets every 4 hours
Do not to take more than 10 caplets in 24 hours
Children under 12 years: ask a doctor
Other information
Inactive ingredients
corn starch, crospovidone, FD&C yellow #6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide
Questions? 1-800-835-2263
91462
PhysiciansCare®
Non-Drowsy
Cold & Cough
Cold, Cough and Flu Relief
Pull
to Open
COATED CAPLET
Individually packaged for workplace use
Tamper-Evident Packets of 2 Caplets
Do not use if packet is open or torn.
Not Actual Size
100 Caplets (50 Packets, 2 caplets each)
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