FDA Label for Walgreens Childrens Cold Plus Cough Plus Runny Nose
View Indications, Usage & Precautions
- OTHER
- OTC - PURPOSE
- USES
- 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
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
Walgreens Childrens Cold Plus Cough Plus Runny Nose Product Label
The following document was submitted to the FDA by the labeler of this product Walgreens Co.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
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 | Antihistamine |
Dextromethorphan HBr 5 mg | Cough suppressant |
Uses
▪ temporarily relieves the following cold/flu symptoms:▪ minor aches and pains▪ headache▪ sore throat▪ sneezing and runny nose▪ cough
▪ temporarily reduces fever
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
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.
Overdose Warning
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.
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 | 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
• 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
Inactive Ingredients
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?
1-866-467-2748
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 Relief
Acetaminophen - Pain Reliever-Fever Reducer
Chlorpheniramine Maleate - Antihistamine
Dextromethorphan HBr - Cough Suppressant
Oral Suspension
Ages 6-11 Years
• Fever• Sore Throat• Sneezing• Runny Nose• 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.
* Please review the disclaimer below.