FDA Label for Childrens Cold And Allergy
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS (IN EACH 5 ML, 1 TEASPOON)
- PURPOSE
- 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 THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- PRINCIPAL DISPLAY PANEL
- PACKAGE LABEL
Childrens Cold And Allergy Product Label
The following document was submitted to the FDA by the labeler of this product Select Brand Dist.. 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 5 Ml, 1 Teaspoon)
Brompheniramine maleate, USP 1 mg
Phenylephrine HCl, USP 2.5 mg
Purpose
Antihistamine
Nasal decongestant
Uses
- temporarily relieves 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
- to sedate a child or to make a child sleepy
- 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.
Ask A Doctor Before Use If You Have
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- glaucoma
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
Ask A Doctor Or Pharmacist Before Use If You Are
- taking any other oral nasal decongestant or stimulant
- 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
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep This And All Drugs Out Of The Reach Of Children.
In case of accidental overdose, seek professional assistance or contact a Poison Control Center (1-800-222-1222) immediately.
Directions
- do not take more than 6 doses in a 24-hour period
- use enclosed dosage cup
- tsp = teaspoon, mL = milliliter
age | dose |
adults and children 12 years and over | 4 teaspoons (20 mL) every 4 hours |
children 6 to under 12 years | 2 teaspoons (10 mL) every 4 hours |
children under 6 years | do not use |
Other Information
- each teaspoon contains: sodium 3 mg
- store at room temperature
Inactive Ingredients
blue #1, citric acid, flavor, glycerin, propylene glycol, purified water, red 40, sodium benzoate, sodium citrate, sorbitol, sucralose
Principal Display Panel
Children's Cold & Allergy Elixir
RELIEVES:
Stuffy Nose; Itchy, Watery Eyes; Runny Nose; Sneezing
Brompheniramine Maleate - Antihistamine
Phenylephrine HCl - Nasal Decongestant
*Compare to the Active Ingredients of DIMETAPP® Elixir
Grape Flavor
Alcohol Free
FL OZ (mL)
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL ON THE BOTTLE IS BROKEN OR MISSING.
*This product is not manufactured or distributed by Wyeth Consumer Healthcare, distributors of Dimetapp®.
DISTRIBUTED BY: SELECT BRAND® DISTRIBUTORS
Pine Bluff, AR 71603 USA
AC (870) 535-3635
MADE IN THE USA
Package Label
Select Brand Children's Cold & Allergy Grape Elixir
* Please review the disclaimer below.