NDC 0363-7920 Walgreens Childrens Cold Plus Cough Plus Runny Nose
Acetaminophen, Chlorpheniramine Maleate, And Dextromethorphan Hydrobromide Suspension Or...
What is NDC 0363-7920?
The NDC code 0363-7920 is assigned by the FDA to the product Walgreens Childrens Cold Plus Cough Plus Runny Nose which is a human over the counter drug product labeled by Walgreens Co.. The generic name of Walgreens Childrens Cold Plus Cough Plus Runny Nose is acetaminophen, chlorpheniramine maleate, and dextromethorphan hydrobromide. The product's dosage form is suspension and is administered via oral form. The product is distributed in a single package with assigned NDC code 0363-7920-04 1 bottle in 1 carton / 120 ml in 1 bottle. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.
What are the uses for Walgreens Childrens Cold Plus Cough Plus Runny Nose?
This product is used as Active ingredients (in each 5 mL)PurposesAcetaminophen 160 mgPain reliever/fever reducerChlorpheniramine maleate 1 mgAntihistamineDextromethorphan HBr 5 mgCough suppressant. ▪temporarily relieves the following cold/flu symptoms:▪minor aches and pains▪headache▪sore throat▪sneezing and runny nose▪cough▪temporarily reduces fever
|Color(s)||PURPLE (C48327) |
|Flavor(s)||GRAPE (C73391) |
NDC Code 0363-7920-04
Package Description: 1 BOTTLE in 1 CARTON / 120 mL in 1 BOTTLE
What are Walgreens Childrens Cold Plus Cough Plus Runny Nose Active Ingredients?
- ACETAMINOPHEN 160 mg/5mL - Analgesic antipyretic derivative of acetanilide. It has weak anti-inflammatory properties and is used as a common analgesic, but may cause liver, blood cell, and kidney damage.
- CHLORPHENIRAMINE MALEATE 1 mg/5mL - A histamine H1 antagonist used in allergic reactions, hay fever, rhinitis, urticaria, and asthma. It has also been used in veterinary applications. One of the most widely used of the classical antihistaminics, it generally causes less drowsiness and sedation than PROMETHAZINE.
- DEXTROMETHORPHAN HYDROBROMIDE 5 mg/5mL - Methyl analog of DEXTRORPHAN that shows high affinity binding to several regions of the brain, including the medullary cough center. This compound is an NMDA receptor antagonist (RECEPTORS, N-METHYL-D-ASPARTATE) and acts as a non-competitive channel blocker. It is one of the widely used ANTITUSSIVES, and is also used to study the involvement of glutamate receptors in neurotoxicity.
Walgreens Childrens Cold Plus Cough Plus Runny Nose Active Ingredients UNII Codes
- ACETAMINOPHEN (UNII: 362O9ITL9D)
- ACETAMINOPHEN (UNII: 362O9ITL9D) (Active Moiety)
- CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z)
- CHLORPHENIRAMINE (UNII: 3U6IO1965U) (Active Moiety)
- DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH)
- DEXTROMETHORPHAN (UNII: 7355X3ROTS) (Active Moiety)
NDC to RxNorm Crosswalk
- RxCUI: 1086750 - acetaminophen 160 MG / chlorpheniramine maleate 1 MG / dextromethorphan HBr 5 MG in 5 mL Oral Suspension
- RxCUI: 1086750 - acetaminophen 32 MG/ML / chlorpheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral Suspension
- RxCUI: 1086750 - acetaminophen 160 MG / chlorpheniramine maleate 1 MG / dextromethorphan hydrobromide 5 MG per 5 ML Oral Suspension
- RxCUI: 1086750 - APAP 32 MG/ML / Chlorpheniramine Maleate 0.2 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML Oral Suspension
Walgreens Childrens Cold Plus Cough Plus Runny Nose Inactive Ingredients UNII Codes
- 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)
- Histamine H1 Receptor Antagonists - [MoA] (Mechanism of Action)
- Histamine-1 Receptor Antagonist - [EPC] (Established Pharmacologic Class)
- Sigma-1 Agonist - [EPC] (Established Pharmacologic Class)
- Sigma-1 Receptor Agonists - [MoA] (Mechanism of Action)
- Uncompetitive N-methyl-D-aspartate Receptor Antagonist - [EPC] (Established Pharmacologic Class)
- Uncompetitive NMDA Receptor Antagonists - [MoA] (Mechanism of Action)
* Please review the disclaimer below.
Walgreens Childrens Cold Plus Cough Plus Runny Nose Product Label
FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Product Label Table of Contents
- OTC - PURPOSE
- LIVER WARNING
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOUR CHILD HAS
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOUR CHILD IS
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- OTC - KEEP OUT OF REACH OF CHILDREN
- OVERDOSE WARNING
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
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.
Otc - Purpose
|Active ingredients (in each 5 mL)||Purposes|
Acetaminophen 160 mg
Pain reliever/fever reducer
Chlorpheniramine maleate 1 mg
Dextromethorphan HBr 5 mg
▪temporarily relieves the following cold/flu symptoms: ▪minor aches and pains ▪headache ▪sore throat ▪sneezing and runny nose ▪cough ▪temporarily reduces fever
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
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. ▪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. ▪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 ▪a breathing problem such as chronic bronchitis ▪glaucoma ▪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 ▪taking sedatives or tranquilizers
When Using This Product
▪do not exceed recommended dose (see overdose warning) ▪marked drowsiness may occur ▪sedatives and tranquilizers may increase drowsiness ▪excitability may occur, especially in children
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.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away. (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.
▪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 4 years
do not use
4 to 5 years
do not use unless directed by a doctor
6 to 11 years
Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.
•each 5 mL contains: sodium 3 mg •store at room temperature
TAMPER-EVIDENT: DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS TORN OR MISSING
anhydrous citric acid, carboxymethylcellulose sodium, D&C Red No. 33, edetate disodium, FD&C Blue No. 1, FD&C Red No. 40, flavors, glycerin, microcrystalline cellulose, propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum
Questions Or Comments?
Principal Display Panel
Compare to the active ingredients in Children’s Tylenol® Cold + Cough + Runny Nose*
Children'sCold + Cough +
Runny Nose Relief
Acetaminophen - Pain Reliever-Fever Reducer
Chlorpheniramine Maleate - Antihistamine
Dextromethorphan HBr - Cough Suppressant
Ages 6-11 Years
•Fever •Sore Throat •Sneezing •Runny Nose •Cough
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.
*This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., distributor of Children’s Tylenol® Cold + Cough + Runny Nose.
* Please review the disclaimer below.