CHILDRENS PLUS COUGH AND RUNNY NOSE- acetaminophen, chlorpheniramine maleate and dextromethorphan hydrobromide suspension 
Aaron Industries Inc

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.

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Drug Facts

Active Ingredients

Acetaminophen 160 mg
Chlorpheniramine maleate 1 mg
Dextromethorphan HBr 5 mg

Purposes

Acetaminophen.......................................Pain reliever/fever reducer
Chlorpheniramine maleate.....................Antihistamine
Dextromethorphan HBr..........................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.

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 dosage
(see overdose warning)

• may cause excitability, 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 this and all drugs out of the reach of children.

Overdose Warning: Taking more than the
recommended dose (overdose) could cause serious
health problems, including liver damage. In case of
accidental overdose, seek professional assistance or
contact a Poison Control Center immediately.
Quick medical attention is critical even if you do not
notice any signs or symptoms.

Directions

• do not exceed recommended dosage
(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

Weight (lb)                    Age (yr)                    Dose (tsp or mL)
under 36                         under 4                      do not use
36-47                               4-5                              do not use unlessdirected by a doctor
48-95                               6-11                            2 tsps or 10 mL

Other Information

• dosage cup provided
• store at controlled room temperature

Inactive Ingredients

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

Principal Display Panel

Childrens Plus Cough and Runny Nose

Acetaminophen Fever and sore throat

Chlorpheniramine maleate Runny nose and sneezing

Dextromethorphan HBr cough

Cherry

For ages 6 to 11

Alcohol .02 percent

Oral suspension

4 fl oz 118mL

image of label

CHILDRENS PLUS COUGH AND RUNNY NOSE 
childrens tylenol plus cough and runny nose suspension
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:49580-2424
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 
CELLULOSE, MICROCRYSTALLINE 
CITRIC ACID MONOHYDRATE 
GLYCERIN 
HIGH FRUCTOSE CORN SYRUP 
WATER 
D&C RED NO. 33 
FD&C RED NO. 40 
SODIUM BENZOATE 
SORBITOL 
XANTHAN GUM 
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRY (Childrens Tylenol Type Cherry Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49580-2424-4118 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/01/2009
Labeler - Aaron Industries Inc (101896231)
Registrant - Aaron Industries Inc (113044205)
Establishment
NameAddressID/FEIBusiness Operations
Aaron Industries Inc113044205manufacture(49580-2424), analysis(49580-2424)

Revised: 6/2013
 
Aaron Industries Inc