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FDA Label NDC 72288-649
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Amazon.com Services Llc for the product Amazon (NDC 72288-649). 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 other, otc - purpose, uses, otc - do not use, ask a doctor before use if the child has, otc - when using, stop use and ask a doctor if, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| Active ingredients (in each 5 mL) | Purposes |
|---|---|
Dextromethorphan HBr 5 mg | Cough suppressant |
Guaifenesin 100 mg | Expectorant |
Phenylephrine HCl 2.5 mg | Nasal decongestant |
Uses
▪ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive▪ temporarily relieves:▪ cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants▪ the intensity of coughing▪ the impulse to cough to help your child get to sleep▪ nasal congestion due to a cold▪ stuffy nose
Otc - Do Not Use
Do not use 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.
Ask A Doctor Before Use If The Child Has
▪ heart disease▪ high blood pressure▪ thyroid disease▪ diabetes▪ cough that occurs with too much phlegm (mucus)▪ persistent or chronic cough such as occurs with asthma
Otc - When Using
When using this product do not use more than directed
Stop Use And Ask A Doctor If
▪ nervousness, dizziness or sleeplessness occur▪ symptoms do not get better within 7 days or occur with fever▪ cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. 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 at 1-800-222-1222.
Directions
▪ do not give more than 6 doses in any 24-hour period▪ measure only with dosing cup provided▪ do not use dosing cup with other products▪ dose as follows or as directed by a doctor
| Age | Dose |
|---|---|
children 6 years to under 12 years of age | 10 mL every 4 hours |
children 4 years to under 6 years of age | 5 mL every 4 hours |
children under 4 years of age | do not use |
Other Information
▪ each 5 mL contains: sodium 2 mg▪ store at room temperature▪ do not refrigerate▪ dosing cup provided
Inactive Ingredients
anhydrous citric acid, edetate disodium, FD&C Blue No.1, FD&C Red #40, flavors, potassium citrate. propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum
Questions Or Comments?
1-866-467-2748
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*Compare to the Active Ingredients in Children’sMucinex® Multi-Symptom Cold
NDC 72288-649-04
Children’s
Multi-Symptom Cold
Dextromethorphan HBr 5 mg - Cough Suppressant
Guaifenesin 100 mg - Expectorant
Phenylephrine HCl 2.5 mg - Nasal Decongestant
- Relieves Stuffy Nose
- Controls Cough
- Relieves Chest Congestion
- Breaks up Mucus
Dosing Cup Included
For Ages 4 & Over
Berry Flavor
Naturally & Artificially Flavored
4 FL OZ (118 mL)
TAMPER EVIDENT: DO NOT USE IF NECKBAND ON BOTTLE CAP IS BROKEN OR MISSING.
IMPORTANT: Keep this carton for future reference on full labeling.
*This product is not manufactured or distributed by Reckitt Benckiser, distributor of Children’s Mucinex® Multi-Symptom Cold.
Amazon Children's M/s Cold Berry Flavor 4 Fl Oz (Childrens 01)
* Please review the disclaimer below.
