FDA Label for Signature Care Childrens Multi Symptom Cold
View Indications, Usage & Precautions
Signature Care Childrens Multi Symptom Cold Product Label
The following document was submitted to the FDA by the labeler of this product Safeway. 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
DISTRIBUTED BY
BETTER LIVING BRANDS LLC
P.O. BOX 99
PLEASANTON, CA 94566-0009
1-888-723-3929
www.betterlivingbrandsLLC.com
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 take 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 | 10 mL every 4 hours |
children 4 years to under 6 years | 5 mL every 4 hours |
children under 4 years | 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
Principal Display Panel
COMPARE TO ChildrenMucinex® Multi-Symptom Cold active ingredients*
NDC 21130-162-04
Signature SELECT
Children’s Multi-Symptom Cold
FOR AGES 4 & OVER
BERRY FLAVOR
NATURALLY & ARTIFICIALLY FLAVORED
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
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.
* Please review the disclaimer below.
