CHILDRENS PLUS COUGH AND SORE THROAT- acetaminophen,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.

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Drug Facts

Active ingredient

Acetaminophen 160 mg

Dextromethorphan HBr 5mg

Purpose

Pain reliever/fever reducer

Cough Suppressant

Uses

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

Warnings

Sore throat warning Severe or persistent sore throat
or sore throat accompanied by fever, headache,
nausea, and vomiting may be serious. Consult
physician promptly. Do not use more than 2 days or
administer to children under 2 years of age unless
directed by a physician.

Do not use

• 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 acetaminophen containing
products. This may lead to an overdose, which
may cause liver damage. (see overdose warning)

Ask a doctor before use if the child has

• chronic cough that lasts as occurs with asthma
• cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if your child

is taking the blood thinning drug warfarin.

When using this product

• do not exceed recommended dosage
(see overdose warning)

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
• nervousness, dizziness or sleeplessness occurs
• 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.

Enter section text here

Overdose Warning

Taking more than the
recommended dose (overdose) could cause serious
health problems, including liver damage. In case of
overdose, get medical help or contact the Poison
Control Center right away. 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
• 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 24     under 2           ask a doctor
24-47         2-5                 1 teaspoon or 5 mL
48-95         6-11               2 teaspoons 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

Walgreens

Children's Plus Cough and Sore Throat

Fever Reducer/ Pain Reliever

Cough Suppressat

Acetaminophen, Dextromethorphan HBr

Cherry Flavor

4 fl oz (118mL)



image of label
CHILDRENS PLUS COUGH AND SORE THROAT 
acetaminophen,dextromethorphan hydrobromide suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0442
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM BENZOATE (UNII: OJ245FE5EU)  
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCERIN (UNII: PDC6A3C0OX)  
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPE (grape flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-0442-44118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/02/200905/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/02/200905/01/2017
Labeler - Walgreens (008965063)

Revised: 5/2017
 
Walgreens