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Drug Facts
Cvs Childrens Nighttime Multi Symptom Cold Liquid
FDA Label NDC 51316-733
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy for the product Cvs Childrens Nighttime Multi Symptom Cold (NDC 51316-733). 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 other, otc - purpose, uses, liver warning:, do not use, ask a doctor before use if the child have, ask a doctor or pharmacist before use if the child is, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| Active ingredients (in each 10 mL) | Purposes |
|---|---|
Acetaminophen 325 mg | Pain reliever/fever reducer |
Diphenhydramine HCl 12.5 mg | Antihistamine/cough suppressant |
Phenylephrine HCl 5 mg | Nasal decongestant |
Uses
▪ temporarily relieves these common cold and flu symptoms:▪ cough▪ nasal congestion▪ minor aches and pains▪ sore throat▪ headache▪ runny nose▪ sneezing
▪ temporarily reduces fever▪ controls cough to help you get to sleep
Liver Warning:
This product contains acetaminophen. Severe liver damage may occur if you take:
▪ more than 5 doses in 24 hours, which is the maximum daily amount▪ with other drugs containing acetaminophen▪ Skin reddening▪ Blisters▪ rash.
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
▪ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.▪ To make child sleepy▪ with any other drug containing diphenhydramine, even one used on the skin▪ in a child who is 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.
Ask A Doctor Before Use If The Child Have
▪ liver disease▪ heart disease▪ high blood pressure▪ thyroid disease▪ diabetes▪ glaucoma▪ a breathing problem such as chronic bronchitis▪ persistent or chronic cough such as occurs with asthma▪ cough that occurs with too much phlegm (mucus)
Ask A Doctor Or Pharmacist Before Use If The Child Is
▪ taking the blood thinning drug warfarin▪ taking sedatives or tranquilizers
When Using This Product
▪ do not use more than directed (see Overdose warning)▪ excitability may occur, especially in children▪ marked drowsiness may occur▪ sedatives and tranquilizers may increase drowsiness
Stop Use And Ask A Doctor If
▪ nervousness, dizziness, or sleeplessness occur▪ pain, nasal congestion, or cough gets worse or lasts more than 5 days▪ fever gets worse or lasts more than 3 days▪ redness or swelling is present▪ new symptoms occur▪ cough comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdose Warning:
Taking more than the recommended dose (overdose) may cause liver damage. 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
▪ this product does not contain directions or complete warnings for adult use▪ do not give more than directed (see Overdose warning)▪ measure only with dosing cup provided▪ do not use dosing cup with other products▪ dose as follows or as directed by a doctor▪ children 6 years to 12 years of age: 10 mL in dosing cup provided every 4 hours while symptoms last; do not give more than 5 doses in 24-hours period▪ children under 6 years of age: do not use
Other Information
▪ each 10 mL contains: sodium 4 mg▪ store at room temperature▪ do not refrigerate
Inactive Ingredients
anhydrous citric acid, edetate disodium, FD&C blue #1, FD&C red #40, natural and artificial flavor, potassium citrate, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.
Questions Or Comments?
1-866-467-2748
Principal Display Panel
Compare to the active ingredients in Children’s Mucinex® Night Time Multi-Symptom Cold
NDC# 51316-733-04
Children’s
Night TimeMuti-Symptom Cold
Diphenhydramine HCl Antihistamine/Cough Suppressant
Phenylephrine HCl Nasal Decongestant
Relieves Stuffy Nose
Controls Cough
Relieves Fever & Sore Throat
Relieves Runny Nose & Sneezing
Dosing Cup Included
For Ages 6 & Over
Very Berry Flavor
Naturally and Artificially Flavored
4 FL OZ (118 mL)
*This product is not manufactured or distributed by RB Health (US), distributor Children’s Mucinex® Nighttime Multi-Symptoms Cold..
TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING.
Distributed by:
Cvs Children's Nighttime Multi-symptoms Cold 4fl Oz 118 mL (Mucinex 01)
* Please review the disclaimer below.
