Label: WALGREENS CHILDRENS COLD PLUS COUGH PLUS RUNNY NOSE- acetaminophen, chlorpheniramine maleate, and dextromethorphan hydrobromide suspension
- NDC Code(s): 0363-7920-04
- Packager: WALGREENS CO.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 12, 2024
If you are a consumer or patient please visit this version.
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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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- to make a child sleepy
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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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- a breathing problem such as chronic bronchitis
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- glaucoma
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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)
Ask a doctor or pharmacist before use if your child is
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- taking the blood thinning drug warfarin
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- taking sedatives or tranquilizers
When using this product
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- do not exceed recommended dose (see overdose warning)
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- marked drowsiness may occur
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- sedatives and tranquilizers may increase drowsiness
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- excitability may occur, especially in children
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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
do not use unless directed by a doctor
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 + Runny Nose*
NDC 0363-7920-04
Children'sCold + Cough +
Runny Nose ReliefAcetaminophen - Pain Reliever-Fever Reducer
Chlorpheniramine Maleate - Antihistamine
Dextromethorphan HBr - Cough SuppressantOral Suspension
Ages 6-11 Years
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- Fever
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- Sore Throat
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- Sneezing
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- Runny Nose
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- Cough
Grape Flavor
Naturally and Artificially Flavored
4 FL OZ (120 mL)
IMPORTANT: Keep this carton for future reference on full labeling.
TAMPER-EVIDENT: DO NOT USE IF PRINTED INNER SEAT UNDER CAP IS TORN OR MISSING.
Distributed by:
*This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., distributor of Children’s Tylenol® Cold + Cough + Runny Nose.
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INGREDIENTS AND APPEARANCE
WALGREENS CHILDRENS COLD PLUS COUGH PLUS RUNNY NOSE
acetaminophen, chlorpheniramine maleate, and dextromethorphan hydrobromide suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-7920 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 Chlorpheniramine Maleate (UNII: V1Q0O9OJ9Z) (Chlorpheniramine - UNII:3U6IO1965U) Chlorpheniramine Maleate 1 mg in 5 mL Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide 5 mg in 5 mL Inactive Ingredients Ingredient Name Strength anhydrous citric acid (UNII: XF417D3PSL) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) D&C red no. 33 (UNII: 9DBA0SBB0L) EDETATE DISODIUM (UNII: 7FLD91C86K) FD&C blue no. 1 (UNII: H3R47K3TBD) FD&C red no. 40 (UNII: WZB9127XOA) glycerin (UNII: PDC6A3C0OX) microcrystalline cellulose (UNII: OP1R32D61U) PROPYL GALLATE (UNII: 8D4SNN7V92) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) water (UNII: 059QF0KO0R) sodium benzoate (UNII: OJ245FE5EU) sorbitol (UNII: 506T60A25R) sucrose (UNII: C151H8M554) xanthan gum (UNII: TTV12P4NEE) Product Characteristics Color PURPLE Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-7920-04 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 M013 02/24/2023 Labeler - WALGREENS CO. (008965063)
