CHILDRENS PLUS FLU WITH PE- acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride suspension 
CVS Pharmacy

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
Phenylephrine HCI 2.5 mg

Purposes

Acetaminophen.......................................Pain reliever/fever reducer
Chlorpheniramine maleate.....................Antihistamine
Dextromethorphan HBr..........................Cough suppressant
Phenylephrine HCI.................................Nasal decongestant

Uses

• temporarily relieves the following cold/flu
symptoms: • minor aches and pains • headache
• sore throat • stuffy nose • cough
• 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 • thyroid disease • diabetes • high blood pressure
• heart disease • a breathing problem such as
chronic bronchitis • persistent or chronic cough
such as occurs with asthma • cough that occurs
with too much phlegm (mucus) • 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

• nervousness, dizziness or sleeplessness occur
• redness or swelling is present
• pain, nasal congestion or cough gets worse or lasts
for more than 5 days • fever gets worse or lasts for
more than 3 days • new symptoms occur
• 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.

• do not exceed recommended dosage
(see overdose warning)
• 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

carboxymethylcellulose sodium, cellulose, citric acid,
flavors, glycerin, purified water, red 33, red 40,
sodium benzoate, sorbitol, sucrose, xanthan gum

Principal Display Panel

CVS Pharmacy

Compare to the active Ingredients in Children's Tylenol Plus Flu

Children's Flu Relief Suspension Liquid

Pain Reliever / Fever Reducer / Antihistamine / Cough Suppressant / Nasal Decongestant

Bubble Gum Flavor

4 FL OZ (118 ML)

image of label


CHILDRENS PLUS FLU  WITH PE
acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-144
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160 mg  in 5 mL
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE1 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL (UNII: 506T60A25R)  
SUCROSE (UNII: C151H8M554)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
Color    Score    
ShapeSize
FlavorBUBBLE GUM (bubble gum) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-144-44118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/14/200903/31/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34109/14/200903/31/2017
Labeler - CVS Pharmacy (062312574)

Revised: 5/2017
 
CVS Pharmacy