FDA Label for Guaiatussin Ac Sugar Free
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS (IN EACH 5 ML TEASPOONFUL)
- PURPOSES
- USES
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- 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?
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
Guaiatussin Ac Sugar Free Product Label
The following document was submitted to the FDA by the labeler of this product Cardinal Health 107, Llc. 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 Teaspoonful)
Codeine Phosphate, USP 10 mg
Guaifenesin, USP 100 mg
Purposes
Cough Suppressant
Expectorant
Uses
• temporarily relieves cough due to minor throat and bronchial irritations as may occur with the common cold or inhaled irritants• helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive
Do Not Use
• in adults and children who have a chronic pulmonary disease or shortness of breath, or children who are taking other drugs, unless directed by a doctor
Ask A Doctor Before Use If You Have
• a cough with too much phlegm (mucus)• a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema
Ask A Doctor Or Pharmacist Before Use If You Are
taking sedatives, tranquilizers and drugs used for depression, especially monoamine oxidase inhibitors (MAOIs). These combinations may cause greater sedation (drowsiness) than is caused by the product used alone.
Stop Use And Ask A Doctor If
• cough lasts more than 7 days, comes back, or occurs with fever, rash or headache that lasts. These can be signs of a serious condition.• may cause or aggravate constipation
If Pregnant Or Breast-Feeding
ask a health professional before use.
Keep Out Of Reach Of Children
In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.
• Use of codeine-containing preparations is not recommended for children under 2 years of age
Directions
• take every 4 hours• do not exceed 6 doses in 24 hours• a special measuring device should be used to give an accurate dose of this product to children under 6 years of age• giving a higher dose than recommended by a doctor can result in serious side effects for a child
adults and children 12 years and over | 2 teaspoonfuls |
children 6 to under 12 years of age | 1 teaspoonfuls |
children under 6 years of age | Consult a doctor |
Other Information
• each (5 mL) teaspoon contains: 1 mg sodium• Tamper evident: Do not use if seal under cap is broken or missing.• Keep container closed and away from heat.• Store at room temperature 15°- 30°C (59°-86°F)
Inactive Ingredients
alcohol 3.5% v/v, artificial cherry flavor, caramel, citric acid, FD&C red # 40, glycerin, polyethylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol solution.
Questions Or Comments?
Call 1-800-932-5676, Mon.-Thurs 9:00 am thru 4:30 pm EST, Fri. 9:00 am thru 2:30 pm EST.
Serious side effects associated with use of this product may be reported to this number.
Distributed By:
Cardinal Health
Dublin, OH 43017
LC2838411118
Package/Label Principal Display Panel
Guaiatussin AC CV
5 Cups
Delivers 5 mL
* Please review the disclaimer below.