Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
DLC Laboratories, Inc.
093351930
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Bactimicina Childrens Cough and Cold
Product Details
Drug Labeling Information
Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label
Long Acting
Voltee Para
Espanol
TRUSTED SINCE 1978
Children's
Bactimicina®
Ages 6+ Years
Milti-Symptom • Liquid
Cough & Cold
Dextromethorphan HBr (Cough Suppressant)
Chlorpheniramine Maleate (Antihistamine)
Relieves Cough up to 8hrs
Sneezing • Runny Nose
Alcohol Free• Sugar Free
Natural Strawberry Flavor
4 FL OZ (118 mL) Dosing Cup Included
INDICATIONS & USAGE SECTION
Uses
- temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
- temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- itchy, watery eyes
- sneezing
- itching of the nose or throat
DOSAGE & ADMINISTRATION SECTION
Directions
- do not take more than 4 doses in any 24-hour period
- mL=mililiter; tsp=teaspoonful
|
Age (years) |
Dose |
|---|---|
|
Under 6 |
do not use |
|
6-11 |
2 teaspoons (10 mL) every 6 hours |
|
12 and over |
4 teaspoons (20 mL) every 6 hours |
WARNINGS SECTION
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
- trouble urinating due to an enlarged prostate gland
- glaucoma
- a cough that occurs with too much phlegm (mucus)
- a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
Ask a doctor or pharmacist before use if you aretaking sedatives or tranquilizers.
When using this product
*do not use more than directed
-
marked drowsiness may occur
-
avoid alcoholic drinks
-
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 cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs 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.
STORAGE AND HANDLING SECTION
Other information
*each teaspoon (5 mL) contains: sodium 1 mg
- store at 15-30°C (59-86°F)
- measure only with dosage cup provided *do not use if printed bottle wrap is missing or broken.
OTC - ACTIVE INGREDIENT SECTION
|
Active ingredients (in each 5 mL = 1 teaspoon) |
Purposes |
|---|---|
|
Chlorpheniramine maleate, USP 1 mg |
Antihistamine |
|
Dextromethorphan HBr, USP 7.5 mg |
Cough suppressant |
OTC - QUESTIONS SECTION
Questions
1-800-858-3889
SPL UNCLASSIFIED SECTION
Manufactured by:
DLC Laboratories, Inc.
Paramount, CA 90723 USA
INACTIVE INGREDIENT SECTION
Inactive ingredients
citric acid, FD&C red no. 40, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose