Active Ingredient
Acetaminophen 325 mg
Chlorpheniramine maleate 2 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCI 5 mg
The following Structured Product Label (SPL) was submitted to the FDA by Allegiant Health for the product Cold Multi-symptom (NDC 69168-319). 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 active ingredient, purpose, uses, liver warning, sore throat warning, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Acetaminophen 325 mg
Chlorpheniramine maleate 2 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCI 5 mg
Pain reliever/fever reducer
Antihistamine
Cough suppressant
Nasal decongestant
temporarily relieves these common cold/flu symptoms: minor aches and pains headache sore throat nasal congestion cough sneezing and runny nose sinus congestion and pressure helps clear nasal passages relieves cough to help you sleep temporarily reduces fever
This product contains acetaminophen. Severe liver damage may occur if you take more than 12 caplets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product
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.
with any other products containing acetaminophen (prescription or nonprescription). If you are not
sure whether a drug contains acetaminophen, ask a doctor or pharmacistif 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 drugs. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product
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, or emphysema cough that occurs with too much phlegm (mucus) a breathing problem such as emphysema or chronic bronchitis glaucoma
taking the blood thinning drug warfarin taking sedatives or tranquilizers
do not use exceed recommended dosage excitability may occur, especially in children marked drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery
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
ask a health professional before use
In case of accidental overdose, contact a doctor or Poison Control Center immediately (1-800-222-1222). Taking more than the recommended dose (overdose) may cause liver damage. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
■ do not take more than directed (see Warnings)
Adults and children 12 years and over: ■ take 2 caplets every 4 hours ■ do not take more than a total of 12 caplets in 24 hours
Children under 12 years: Do not use this adult product in children under 12 years of age. This will provide more than recommended dose (overdose) and may cause liver damage
store between 15-30°C (59-86°F) do not use if blister is torn or open
colloidal silicone dioxide, corn starch, croscarmellose sodium, FD&C Blue #1, FD&C Lake Black, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid, titanium dioxide
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