Otc - Active Ingredient
Active Ingredients (in each capsule)Acetaminophen 250 mg Phenylepherine Hydrochloride 5 mgChlorpheniramine Maleate 2 mgDextromethorphan Hydrobromide 10 mg
Cough And Cold Capsule, Liquid Filled
FDA Label NDC 63654-800
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Selder, S.a. De C.v. for the product Cough And Cold (NDC 63654-800). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - ask doctor, otc - ask doctor/pharmacist, otc - stop use, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
PurposeAnalgesicDecongestantAntihistamine Antitussive
Indications & Usage
Uses temporarily relieves these symptoms due to common cold and allergies: • cough • nasal congestion • runny nose • sneezing • watery eyes • fever • aches and pains
Warnings
Warnings Do not use •more than recommended dosage • for pain more than 7 days • for fever more than 3 days for children under 12 years of age • with any other product containing acetaminophen Alcohol warning • if you consume 3 or more alcoholic drinks every day, ask your doctor if you sghould take acetaminophenor other pain relievers/fever reducers. Acetaminophen may cause liver damage
Otc - Ask Doctor
Ask a doctor before use you have• glaucoma • breathing problem such as emphysema or chronic bronchitis • heart disease • diabetes • thyroid disease • difficulty in urination due to enlargement of the prostate gland
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives Do not take this product for persistent or chronic cough such as occur with smoking, asthma or emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor
Otc - Stop Use
Stop taking this product and ask a doctor if you have • pain • fever or symptoms that persist or get worse • new symptoms occur• redness or swelling • these may be signs of a serious condition.
Otc - When Using
When using this product• you may get drowsy • avoid alcoholic drinks• alcohol, sedatives and tranquilizers may increase drowsiness• use caution when driving a motor vehicle or operating machinery• excitability may occur, especially in childrenIf nervousness, dizziness or sleeplessness occur discontinue use and consult a doctorIf symptoms do not improve within 7 days, or are accompanied by fever, consult a doctorIf pregnant or breast feeding, ask a health professional before use
Otc - Keep Out Of Reach Of Children
Keep this and all drugs out of the reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center immediately. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.
Other
Drug Interaction Precautions• Do not use if you are taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, orParkinson’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.
Dosage & Administration
Directions Adults and children 12 years of age and older; take 2 capsules every 4 hours. Do not take more than 12 capsules in 24 hours, unless directed by a doctor. For children under 12 years of age, consult a doctor
Inactive Ingredient
Inactive Ingredients DC Red No. 33, FDC Blue No. 1, gelatin, glycerin, polyethylene glycol 600, polyethylene glycol 1000, povidone, polyethylene glycol, water
Package Label.Principal Display Panel
Package Label
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