NDC | 58407-920-10, 58407-920-16 |
Set ID | e61129db-2ee2-4e0c-ab2b-c5f26e62abfc |
Category | HUMAN OTC DRUG LABEL |
Packager | Magna Pharmaceuticals, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART341 |
- Drug Facts
Active ingredients
(in each 5 mL teaspoonful)
Chlorpheniramine Maleate 2 mg
Codeine Phosphate* 9 mg
*(Warning: May be habit-forming)
Close - Purpose
- Uses
temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:
- runny nose
- sneezing
- itching of the nose or throat
- itchy, watery eyes
- cough due to minor throat and minor bronchial irritation
- WARNINGS
- ASK DOCTOR
Ask a doctor before use if you have
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- difficulty in urination due to enlargement of the prostate gland
- a persistent or chronic cough such as occurs with smoking, asthma or emphysema
- a cough that occurs with too much phlegm (mucus)
- a chronic pulmonary disease, shortness of breath, or children who are taking other drugs
- ASK DOCTOR
- WHEN USING
When using the product
- excitability may occur, especially in children
- may cause marked drowsiness
- avoid alcoholic beverages
- alcohol, sedatives, and tranquilizers may increase the drowsiness effect
- be careful when driving a motor vehicle or operating machinery
- STOP USE
Stop use and ask a doctor if
- cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition
- may cause or aggravate constipation
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Close - DOSAGE & ADMINISTRATION
Directions
Do not exceed recommended dosage.
Adults and Children
12 years of age and
over:
2 teaspoonfuls (10 mL)
every 4-6 hours, not to
exceed 12 teaspoonfuls
in a 24 hour period.
Children 6 to under
12 years of age:
1 teaspoonful (5 mL)
every 4-6 hours, not to
exceed 6 teaspoonfuls
in a 24 hour period.
Children under 6
years of age:
Consult a doctor. 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 could result in serious effects for your child.
Close - STORAGE AND HANDLING
- INACTIVE INGREDIENT
Inactive ingredients
Cherry Flavor, Citric Acid, FD&C Red No. 40, Glycerin, Propylene Glycol, Purified Water, Sodium Citate, Sodium Saccharin, Sorbitol.
Close - QUESTIONS
- Z-Tuss AC 473 mL (1 Pint) Label
- INGREDIENTS AND APPEARANCE
Z-TUSS AC
chlorpheniramine maleate, codeine phosphate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58407-920 Route of Administration ORAL DEA Schedule CV Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 2 mg in 5 mL CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J) CODEINE PHOSPHATE 9 mg in 5 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM CITRATE (UNII: 1Q73Q2JULR) SORBITOL (UNII: 506T60A25R) Product Characteristics Color Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58407-920-16 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/11/2011 2 NDC:58407-920-10 10 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/27/2011 09/30/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 01/11/2011 Labeler - Magna Pharmaceuticals, Inc. (620988360)