Active Ingredients (In Each 5 Ml)
Acetaminophen 160 mg
Chlorpheniramine maleate 1 mg
Dextromethorphan HBr 5 mg
Phenylephrine HCl 2.5 mg
Childrens Multi Symptom Fever And Cold
FDA Label NDC 0363-0789
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Walgreen Co. for the product Childrens Multi Symptom Fever And Cold (NDC 0363-0789). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients (in each 5 ml), purposes, uses, warnings, do not use, ask a doctor before use if the child has, ask a doctor or pharmacist before use if the child is, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purposes
Pain reliever/fever reducer
Antihistamine
Cough suppressant
Nasal decongestant
Uses
- temporarily relieves
- minor aches and pains
- headache
- minor sore throat pain
- runny nose
- itchy nose or throat
- sneezing
- itchy, watery eyes due to hay fever
- nasal and sinus congestion
- cough due to minor throat and bronchial irritation as may occur with a cold
- temporarily reduces fever
Warnings
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
- skin reddening
- blisters
- rash
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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
- in a child under 4 years of age
- if your child is allergic to acetaminophen
- 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 taking this product.
- for the purpose of making your child sleepy
Ask A Doctor Before Use If The Child Has
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- glaucoma
- a breathing problem such as chronic bronchitis
- cough that occurs with too much phlegm (mucus)
- chronic cough that lasts, such as occurs with asthma
Ask A Doctor Or Pharmacist Before Use If The Child Is
- taking sedatives or tranquilizers
- taking the blood thinning drug warfarin
When Using This Product
- do not exceed recommended dosage
- marked drowsiness may occur
- sedatives and tranquilizers may increase drowsiness
- excitability may occur, especially in children
Stop Use And Ask A Doctor If
- nervousness, dizziness, or sleeplessness occur
- pain, nasal congestion or cough gets worse or lasts more than 5 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. Prompt medical attention is critical 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
- shake well before use
- may be given every 4 hours, while symptoms persist. Do not give more than 5 doses in 24 hours unless directed by a doctor.
- use enclosed dosing cup only. Keep for use with this product. Do not use any other dosing device.
- mL = milliliter
Age | Dose |
children under 4 years | do not use |
children 4 to under 6 years of age | do not use unless directed by a doctor |
children 6 to under 12 years of age | 10 mL |
Other Information
- each 5 mL contains: sodium 5 mg
- Tamper–evident: do not use if printed inner seal under cap is torn or missing
- store at room temperature. Protect from light.
- contains no aspirin
- close cap tightly
Inactive Ingredients
citric acid, D&C Red #33, edetate disodium, FD&C Blue #1, FD&C Red #40, flavor, glycerin, microcrystalline cellulose, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium carboxymethylcellulose, sorbitol, sucrose, xanthan gum
Questions Or Comments?
1-866-467-2748
Principal Display Panel
NDC 0363-0789-04
Walgreens
Compare to Children’s Triaminic® Suspension
Multi-Symptom Fever & Cold active ingredients††
NEW
children’s Multi-Symptom Fever & Cold
ACETAMINOPHEN /
PAIN RELIEVER/FEVER RELIEVER
CHLORPHENIRAMINE MALEATE /
ANITHISTAMINE
DEXTROMETHORPHAN HBR /
COUGH SUPPRESSANT
PHENYLEPHRINE HCL /NASAL CONGESTANT
- Relief of cold & flu symptoms; fever; runny & stuffy nose; aches & pains; sore throat; Cough
AGES 6-11 YEARS
GRAPE FLAVOR
Naturally and Artificially flavored
4 FL OZ (118 mL)
PHARMACIST RECOMMENDED
WALGREENS
†Walgreens Pharmacist Survey
IMPORTANT: KEEP THIS CARTON FOR FUTURE REFERENCE ON FULL LABELING |
††This product is not manufactured or distributed by GSK Consumer Healthcare, owner of the registered trademark Children’s Triaminic Suspension Multi-Symptom Fever and Cold
DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
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