OTC Medication Information: Childrens Plus Cough and Runny Nose

CHILDRENS PLUS COUGH AND RUNNY NOSE- acetaminophen, chlorpheniramine maleate and dextromethorphan hydrobromide suspension
Walgreens

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active ingredients (in each 5 mL)

Acetaminophen 160 mg

Chlorpheniramine maleate 1 mg

Dextromethorphan HBr 5 mg

Purposes

Pain reliever/fever reducer

Antihistamine

Cough suppressant

Uses

  • temporarily relieves the following cold/flu symptoms:
    • minor aches and pains
    • cough
    • headache
    • sore throat
    • sneezing and runny nose
  • temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes:

  • more than 5 doses (10 mL each) in 24 hours, which is the maximum daily amount
  • with other drugs contaning acetaminophen

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

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

  • to make a child sleepy
  • 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 child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
  • with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if your child is allergic to acetaminophen or any of the inactive ingredients in this product.

Ask a doctor before use if the child has

  • Liver disease
  • glaucoma
  • a breathing problem such as chronic bronchitis
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with asthma

Ask a doctor or pharmacist before use if the child is taking

  • sedatives or tranquilizers
  • the blood thinning drug warfarin

When using this product

  • do not exceed recommended dose (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

  • new symptoms occur
  • redness or swelling is present
  • pain or cough gets worse or lasts for more than 5 days
  • fever gets worse or lasts more than 3 days
  • cough comes back or occurs with rash or headache that lasts.

These could be signs of a serious condition.

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 (1-800-222-1222) right away. Quick medical attention is critical even if you do not notice any signs or symptoms.

Directions

  • this product does not contain directions or complete warnings for adult use.
  • mL = milliliter
  • shake well before using
  • do not give more than 5 doses in any 24-hour period
  • measure only with dosing cup provided. Do not use any other dosing device.
  • keep dosing cup with product
  • if needed, repeat dose every 4 hours while symptoms last
  • find the right dose on chart below. If possible, use weight to dose; otherwise, use age
Weight (lb) Age (yr) Dose (mL)
48-95 6-11 10 mL
36-47 4-5 do not use unless directed by a doctor
under 36 under 4 do not use

Other Information

  • store between 20-25ºC (68-77ºF). Do not refrigerate

Inactive ingredients

acesulfame potassium, alcohol, carboxymethylcellulose sodium, citric acid, D&C red #33, FD&C red #40, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose purified water, sodium benzoate, sorbitol, xanthan gum

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to Children’s Tylenol® Plus Cough & Runny Nose active ingredients††

Children’s

Cough & Runny Nose

ACETAMINOPHEN /

PAIN RELIEVER / FEVER REDUCER

CHLORPHENIRAMINE MALEATE /

ANTIHISTAMINE

DEXTROMETHORPHAN HBr /

COUGH SUPPRESSANT

  • Relieves fever, sore throat, aches, sneezing, runny nose & cough
  • Oral suspension
  • ALCOHOL 0.005%

AGES 6 — 11 YEARS

FL OZ (mL)

CHERRY FLAVOR

DOSAGE CUP PROVIDED

††This product is not manufactured or distributed by McNeil Consumer Healthcare,distributor of Children’s Tylenol® Plus Cough & Runny Nose.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

walgreens.com

Package Label

Acetaminophen 160 mg, Chlorpheniramine Maleate 1 mg, Dextromethorphan HBr 5 mg
(click image for full-size original)

WALGREENS Children’s Cough & Runny Nose Cherry Flavor

CHILDRENS PLUS COUGH AND RUNNY NOSE
acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide suspension
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0297
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 160 mg in 5 mL
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE 1 mg in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 5 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
ACESULFAME POTASSIUM
CARBOXYMETHYLCELLULOSE SODIUM
CELLULOSE, MICROCRYSTALLINE
ANHYDROUS CITRIC ACID
GLYCERIN
HIGH FRUCTOSE CORN SYRUP
WATER
D&C RED NO. 33
FD&C RED NO. 40
SODIUM BENZOATE
SORBITOL
XANTHAN GUM
ALCOHOL
Product Characteristics
Color Score
Shape Size
Flavor CHERRY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0363-0297-04 1 BOTTLE, PLASTIC in 1 BOX contains a BOTTLE, PLASTIC
1 118 mL in 1 BOTTLE, PLASTIC This package is contained within the BOX (0363-0297-04)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part341 07/31/2015
Labeler — Walgreens (008965063)

Revised: 10/2019 Walgreens

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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