Nighttime Childrens Multi Symptoms Solution
FDA Label NDC 49035-545

15 label sections · Submitted to the FDA by Wal-mart Stores,inc. · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Wal-mart Stores,inc. for the product Nighttime Childrens Multi Symptoms (NDC 49035-545). 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, do not use, ask a doctor before use if you have, otc - ask doctor/pharmacist, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Otc - Purpose

Active ingredients
(in each 15 mL)		Purpose

Chlorpheniramine maleate 2 mg

Antihistamine

Dextromethorphan HBr 15 mg

Cough suppressant

Uses

temporarily relieves cold symptoms:

  • cough due to minor throat & bronchial irritation
  • sneezing
  • runny nose

Do Not Use

  • 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.
  • to make a child sleep

Ask A Doctor Before Use If You Have

  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
  • trouble urinating due to enlarged prostate gland

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you aretaking sedatives or tranquilizers.

When Using This Product

  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery
  • alcohol, sedatives, & tranquilizers may increase drowsiness

Stop Use And Ask A Doctor If

  • cough persists more than 1 week, tends to recur or is accompanied by fever, rash, or persistent headache.

    • These could be signs of a serious condition.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Directions

  • take only as directed
  • do not exceed 4 doses per 24 hrs.
  • only use the dose cup provided

    • adults & children 12 yrs & over

    30 mL every 6 hrs.

    children 6 to under 12 yrs

    15 mL every 6 hrs.

    children 4 to under 6 yrs

    do not use unless directed by a doctor

    children under 4 yrs

    do not use

Other Information

  • each 15 mL contains:potassium 5 mg, sodium 5 mg
  • store at room temperature

Inactive Ingredients

anhydrous citric acid, FD&C Red No. 40, flavor, potassium citrate, potassium sorbate, propylene glycol, purified water, sodium benzoate, sorbitol, sucrose

Questions Or Comments?

1-888-287-1915

Principal Display Panel - 236 Ml Bottle Label

Compare to Children’s Vicks Nyquil™ active ingredients*

equate™

NDC 49035-545-08

Childrens

Sugar-Free

Multi-Symptoms
Cold & Cough

NIGHTTIME

Chlorpheniramine maleate 2 mg,

Dextromethorphan HBr 15 mg

  • Sneezing
  • Runny Nose
  • Cough

    • Aspirin-Free

    Acetaminophen-Free

    Natural Cherry Flavor

    Free of Alcohol & Acetaminophen

    8 FL OZ (236 ml)

    DISTRIBUTED BY: Walmart Inc.,

    Bentonville, AR 72716

    Made in the USA

    With domestic and imported ingredients Factory Certified

    TAMPER EVIDENT:Do not use if printed shrink band is missing or broken.

    *This product is manufactured or distributed by Procter & Gamble, the distributor of Children’s Vicks ®Nyquil™

    Satisfaction guaranteed – Or we’ll replace it or give you your money back. For questions or comments or to report an undesired reaction or side effect, please call 1-888-287-1915

    Walmart Nighttime Children's Multi Symptom Cold And Cough (Nyquil 01)

    Walmart Nighttime Children's Multi Symptom Cold And Cough (Nyquil 01)

* Please review the disclaimer below.