OTC Medication Information: Childrens Cold and Allergy
CHILDRENS COLD AND ALLERGY- brompheniramine maleate and phenylephrine hydrochloride elixir
Select Brand Dist.
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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
Warnings
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
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Labeler — Select Brand Dist. (012578514) |
Revised: 10/2014 Select Brand Dist.
Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.
https://otclabels.com/lib/otc/otc-meds/childrens-cold-and-allergy-2/