WALGREEN CHILDRENS COLD PLUS COUGH PLUS SORE THROAT- acetaminophen and dextromethorphan hydrobromide suspension 
WALGREENS CO.

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Walgreens Children's Cold + Cough + Sore Throat Relief

Drug Facts

Active ingredients (in each 5 mL)Purposes

Acetaminophen 160 mg

Pain reliever/fever reducer

Dextromethorphan HBr 5 mg

Cough suppressant

Uses

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

with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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.
if your child has ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if your child has

liver disease
persistent or chronic cough such 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 dose (see overdose warning)

Stop use and ask a doctor if

pain or cough gets worse or lasts more than 5 days
fever gets worse or lasts more than 3 days
new symptoms occur
redness or swelling is present
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

In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. Quick medical attention is critical for adults as well as for children 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 give more than directed (see overdose warning)
shake well before using
mL = milliliter
find right dose on chart below. If possible, use weight to dose; otherwise, use age.
remove the child protective cap and squeeze your child's dose into the dosing cup
repeat dose every 4 hours, while symptoms last
do not give more than 5 times in 24 hours
Weight (lb)Age (yr)Dose (mL)

under 36

under 4 years

do not use

36-47

4 to 5 years

5 mL

48-95

6 to 11 years

10 mL

Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Other information

each 5 mL contains: sodium 3 mg
store at room temperature

Inactive ingredients

carboxymethylcellulose sodium, anhydrous citric acid, D&C red no. 33, disodium edetate, FD&C red no. 40, flavors, glycerin, microcrystalline cellulose, purified water, sodium benzoate, sodium citrate dihydrate, sorbitol solution, sucralose, xanthan gum

Questions or comments?

1-866-467-2748

PRINCIPAL DISPLAY PANEL

Compare to the active ingredients in Children’s Tylenol® Cold + Cough + Sore Throat*

NDC 0363-6504-04

Children's

Cold + Cough

+ Sore Throat Relief

Acetaminophen, Pain Reliever-Fever Reducer
Dextromethorphan HBr, Cough Suppressant

Oral Suspension

Ages 4-11 Years

Fever
Sore Throat
Cough

Ibuprofen free, aspirin free,

No added alcohol

BubblegumFlavor

Naturally and Artificially Flavored

4 FL OZ (120 mL)

*This product is not manufactured or distributed by Johnson & Johnson Consumer Inc, distributor of Children’s Tylenol® Cold + Cough + Sore Throat.

TAMPER-EVIDENT: DO NOT USE IF PRINTED INNER SEAL UNDER CAPS IS TORN OR MISSING.

Walgreens Children's Cold + Cough + Sore Throat Relief 4 FL OZ 120 mL
WALGREEN CHILDRENS  COLD PLUS COUGH PLUS SORE THROAT
acetaminophen and dextromethorphan hydrobromide suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-6504
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
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
SORBITOL SOLUTION (UNII: 8KW3E207O2)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorpinkScore    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-6504-041 in 1 CARTON02/24/2023
1120 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01202/24/2023
Labeler - WALGREENS CO. (008965063)

Revised: 11/2023
Document Id: 6a833ff4-6a49-45a6-9c6d-6e1105011c3c
Set id: 801880b2-6116-4d26-a7bf-a669eef6ad8b
Version: 2
Effective Time: 20231130
 
WALGREENS CO.