Label: WALGREEN CHILDRENS COLD PLUS COUGH PLUS SORE THROAT- acetaminophen and dextromethorphan hydrobromide suspension
- NDC Code(s): 0363-6504-04
- Packager: WALGREENS CO.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 12, 2024
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
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Warnings
Liver warning
This product contains acetaminophen. Severe liver damage may occur if your child takes
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- more than 5 doses in 24 hours, which is the maximum daily amount
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- with other drugs containing acetaminophen
Allergy alert: acetaminophen may cause severe skin reactions.
Symptoms may include:
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- skin reddening
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- blisters
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- 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
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- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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- 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.
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- 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
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- liver disease
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- persistent or chronic cough such as occurs with asthma
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- cough that occurs with too much phlegm (mucus)
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Directions
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- this product does not contain directions or complete warnings for adult use
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- do not give more than directed (see overdose warning)
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- shake well before using
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- mL = milliliter
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- find right dose on chart below. If possible, use weight to dose; otherwise, use age.
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- remove the child protective cap and squeeze your child's dose into the dosing cup
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- repeat dose every 4 hours, while symptoms last
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- 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
- Inactive ingredients
- Questions or comments?
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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 SuppressantOral Suspension
Ages 4-11 Years
- •
- Fever
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- Sore Throat
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- 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.
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INGREDIENTS AND APPEARANCE
WALGREEN CHILDRENS COLD PLUS COUGH PLUS SORE THROAT
acetaminophen and dextromethorphan hydrobromide suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-6504 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 160 mg in 5 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 5 mg in 5 mL Inactive Ingredients Ingredient Name Strength 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 Color pink Score Shape Size Flavor BUBBLE GUM Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-6504-04 1 in 1 CARTON 02/24/2023 1 120 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 02/24/2023 Labeler - WALGREENS CO. (008965063)