FDA Label for Walgreen Childrens Cold Plus Cough Plus Sore Throat
View Indications, Usage & Precautions
- OTHER
- OTC - PURPOSE
- USES
- LIVER WARNING
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOUR CHILD HAS
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
- 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
Walgreen Childrens Cold Plus Cough Plus Sore Throat 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 |
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
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.▪ 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)
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin
Otc - When Using
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.
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 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.
* Please review the disclaimer below.