FDA Label for Cold And Cough Childrens
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
- PRINCIPAL DISPLAY PANEL
- PRODUCT LABEL
Cold And Cough Childrens Product Label
The following document was submitted to the FDA by the labeler of this product Quality Choice (chain Drug Marketing Association). 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 2 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 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
- 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
- thyroid disease
- diabetes
- glaucoma
- high blood pressure
- trouble urinating due to an enlarged prostate gland
- cough that occurs with too much phlegm (mucus)
- a breathing problem or persistent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis, or emphysema
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
- marked drowsiness may occur
- 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
- nervousness, dizziness or sleeplessness occur
- symptoms do not improve within 7 days or are accompanied by fever
- cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache.These could be a sign of a serious condition
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
- do not take more than 6 doses in any 24-hour period
- measure only with dosing cup provided. Do not use any other dosing device
- keep dosing cup with product
- mL = milliliter
Age | Dose |
adults and children 12 years and over | 20 mL every 4 hours |
children 6 to 11 years | 10 mL every 4 hours |
children under 6 years | do not use |
Other Information
- each 10 mL contains: sodium 5 mg
- store between 20-25°C (68-77°F). Do not refrigerate.
Inactive Ingredients
citric acid, FD&C blue #1, FD&C red #40, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose
Principal Display Panel
*Compare to the active ingredients in Children's Dimetapp® Cold & Cough
Children's Dibromm
Cold & Cough
Brompheniramine Maleate Anthihistamine
Dextromethorphan HBr Cough Suppressant
Phenylephrine HCl Nasal Decongestant
For Ages 6 & Over
Alcohol Free
Grape Flavor
FL OZ (mL)
Dosing Cup Included
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.
*This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributor of Children's Dimetapp® Cold & Cough.
Distributed by C.D.M.A., Inc.©
43157 W. Nine Mile
Novi, MI 48376-0995
www.qualitychoice.com
Question: 248-449-9300
Product Label
QUALITY CHOICE Children's Dibromm Cold & Cough Grape Liquid
* Please review the disclaimer below.