FDA Label for Childrens Cold, Cough And Sore Throat
View Indications, Usage & Precautions
Childrens Cold, Cough And Sore Throat Product Label
The following document was submitted to the FDA by the labeler of this product Chain Drug Consortium, Llc. 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.
Active Ingredients
Drug Facts
Active ingredients
(in each 10 mL or 2 teaspoons)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCL 5 mg
Purpose
Purpose
Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant
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.
Uses
- temporarily relieves these common cold and flu symptoms:
- nasal congestion
- minor aches and pains
- headache
- stuffy nose
- sore throat
- fever
- cough due to minor throat and bronchial irritation
- helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
Warnings
Liver warning: This product contains acetaminophen. Sever liver damage may occur if your child if your child takes
- more than 5 doses in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
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
- with any other drugs 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 two weeks after stopping the MAOI drug. If you do not know if your child’s prescription drug contains an MAOI, ask a doctor or a pharmacist before taking this product.
Ask A Doctor Before Use If Your Child Has
- liver disease
- high blood pressure
- diabetes
- heart disease
- thyroid disease
- a breathing problem such as chronic bronchitis
- 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
Stop Use And Ask A Doctor If
- redness or swelling is present
- nervousness, dizziness or sleeplessness occur
- new symptoms occur
- pain, nasal congestion or cough gets worse or lasts more that 5 days
- fever gets worse or lasts more than 3 days
- cough comes back, or occurs with rash or headache that lasts.
These could be signs of a serious condition.
Directions
Directions
- do not use more than directed (see Overdose warning)
- shake well before using
- do not use more than 5 doses in any 24-hour period
- if needed, repeat dose every 4 hours while symptoms last
- do not use more than 5 days unless directed by a doctor
- use dose cup
Age Dose
Children 6 to under 12 years of age 2 teaspoonfuls
Children under 6 years of age do not use
Other Information
- each 10 mL (2 tsp) contains: sodium 5 mg
- store between 15-30 ° C (59-86° F)
- do not refrigerate
- dosing cup provided
Overdose Warning
When using this product
- do not use more than directed (see Overdose warning)
- Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical even if you do not notice any signs or symptoms.
Inactive Ingredients
anhydrous citric acid,edetate disodium, FD and C Blue #1, FD and C Red # 40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum
Questions?
1-877-798-5944
Product Label
NDC 68016-224-00
COMPARE TO THE ACTIVE INGREDIENTS IN CHILDREN’S MUCINEX® COLD, COUGH, and SORE THROAT LIQUID
Premier Value®
Children's Cold, Cough, and Sore Throat
Acetaminophen / Guaifenesin / Dextromethorphan HBr / Phenylephrine HCL
PAIN RELIEVER / FEVER REDUCER
EXPECTORANT
COUGH SUPPRESSANT
NASAL DECONGESTANT
Guaifenesin 100 mg
Dextromethorphan HBr 5 mg
Phenylephrine HCL 2.5 mg
* Cough
* Sore Throat
* Nasal Congestion
* Chest Congestion
For ages 6 to 12
Mixed Berry Flavor
4 FL OZ (118mL)
DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING
INDEPENDENTLY TESTED SATISFACTION GUARANTEED PV
DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING
*This product is not manufactured or distributed by Reckitt Benckiser Inc. distributor of Children’s Mucinex® Cold, Cough and Sore Throat Liquid
If for Any reason you are not satisfied with this product, lease return it to the store where purchased for a full refund.
DISTRIBUTED BY
CHAIN DRUG CONSORTIUM
3301 NW BOCA RATON BLVD
SUITE 101, BOCA RATON, FL 33431
BX028
* Please review the disclaimer below.