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Childrens Plus Cough and Runny Nose

Dosage form: suspension
Ingredients: ACETAMINOPHEN 160mg in 5mL, CHLORPHENIRAMINE MALEATE 1mg in 5mL, DEXTROMETHORPHAN HYDROBROMIDE 5mg in 5mL
Labeler: Chain Drug Consortium, LLC
NDC Code: 68016-130

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.

Drug Facts

Active ingredients

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 in 24 hours, which is the maximum daily amount
  • with other drugs contaning acetaminophen

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
  • 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
  • liver disease

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
  • fever gets worse or lasts for more than 3 days
  • redness or swelling is present
  • pain or cough gets worse or lasts for more than 5 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) could cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately. 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.
  • do not exceed recommended dose (see overdose warning)
  • do not use in infants
  • shake well before using
  • find right dose on chart below. If possible, use weight to dose; otherwise, use age
  • if needed, repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
  • use enclosed dosage cup
  • tsp = teaspoon, mL = milliliter
Weight (lb)Age (yr)Dose (tsp or mL)
 under 36 under 4 do not use
 36-47 4-5 do not use unless directed by a doctor
 48-95 6-11 2 teaspoons or 10 mL

Other Information
  • store at room temperature

Inactive ingredients

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

Questions or comments?

1-866-534-4631

Principal Display Panel

COMPARE TO ACTIVE INGREDIENTS IN CHILDREN'S TYLENOL® PLUS COUGH & RUNNY NOSE* 

Children's Plus Cough and Runny Nose Oral Suspension

Acetaminophen Pain reliever/fever reducer

Chlorpheniramine maleate Antihistamine

Dextromethorphan HBr Cough suppressant

Cherry Flavor

Alcohol .02 percent

FL OZ (mL)

*This product is not manufactured or distributed by McNeil Consumer & Specialty Pharmaceuticals, distributor of Children's Tylenol® Plus Cough & Runny Nose.

DISTRIBUTED BY CHAIN DRUG CONSORTIUM

3301 NW BOCA RATON BLVD

SUITE 101, BOCA RATON, FL 33431

PARENTS: Learn about teen medicine abuse  www.StopMedicineAbuse.org

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL ON THE BOTTLE IS BROKEN OR MISSING.

Package Label

Premier Value Children's Plus Cough & Runny Nose Suspension

CHILDRENS PLUS COUGH AND RUNNY NOSE 
acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-130
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN160 mg  in 5 mL
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE1 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM 
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM 
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    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:68016-130-04118 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34101/01/2009
Labeler - Chain Drug Consortium, LLC (101668460)

 
Chain Drug Consortium, LLC

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Medically reviewed on Oct 26, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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