FDA Label for Signature Care Childrens Cold And Cough
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS (IN EACH 10 ML)
- PURPOSES
- USES
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
Signature Care Childrens Cold And Cough 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.
Active Ingredients (In Each 10 Ml)
Brompheniramine maleate, USP 2 mg
Dextromethorphan HBr, USP 10 mg
Phenylephrine HCl, USP 5 mg
Purposes
Antihistamine
Cough suppressant
Nasal decongestant
Uses
• temporarily relieves cough due to minor throat and bronchial irritation occurring with a cold, and nasal congestion due to the common cold, hay fever or other upper respiratory allergies• temporarily relieves these symptoms due to hay fever (allergic rhinitis):• runny nose• sneezing• itchy, watery eyes• itching of the nose or throat• temporarily restores freer breathing through the nose
Do Not Use
• if you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.• to make a child sleepy
Ask A Doctor Before Use If You Have
• heart disease• high blood pressure• thyroid disease• diabetes• trouble urinating due to an enlarged prostate gland• glaucoma• cough that occurs with too much phlegm (mucus)• a breathing problem such as emphysema or chronic bronchitis• cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
Ask A Doctor Or Pharmacist Before Use If You Are
taking sedatives or tranquilizers
When Using This Product
• do not use more than directed• may cause marked drowsiness• avoid alcoholic beverages• alcohol, sedatives, and tranquilizers may increase drowsiness• be careful when driving a motor vehicle or operating machinery• excitability may occur, especially in children
Stop Use And Ask A Doctor If
• you get nervous, dizzy, or sleepless• symptoms do not get better within 7 days or are accompanied by fever• cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Directions
• do not take more than 6 doses in any 24-hour period• measure only with dosage cup provided• keep dosage cup with product• mL = milliliter
age | dose |
adults and children 12 years and over | 20 mL every 4 hours |
children 6 to under 12 years | 10 mL every 4 hours |
children under 6 years | do not use |
Other Information
• each 10 mL contains: sodium 4 mg• store at 20°-25°C (68°-77°F)
Inactive Ingredients
anhydrous citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol solution
Questions Or Comments?
1-888-723-3929
Principal Display Panel
AGES 6 YRS. & OLDER
Children’s Cold & Cough
Brompheniramine Maleate 2mg - Antihistamine
Dextromethorphan HBr 10mg – Cough Suppressant
Phenylephrine HCl 5mg – Nasal Decongestant
GRAPE FLAVOR
Compare to Children’s Dimetapp® Cold & Cough active ingredients
Relieves Nasal Symptoms:
Stuffy Nose
Runny Nose
Sneezing
Plus Other Symptoms:
Itchy, Watery Eyes
Cough
Alcohol Free
Gluten Free
4 FL OZ (118mL)
* Please review the disclaimer below.