Z-TUSS AC- chlorpheniramine maleate, codeine phosphate liquid

Z-TUSS by

Drug Labeling and Warnings

Z-TUSS by is a Otc medication manufactured, distributed, or labeled by Magna Pharmaceuticals, Inc., Woodfield Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

(in each 5 mL teaspoonful)

Chlorpheniramine Maleate 2 mg

Codeine Phosphate* 9 mg

*(Warning: May be habit-forming)

Purpose

Antihistamine

Antitussive

(Cough Suppressant)

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

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

Ask a doctor before use if you are

taking sedatives or tranquilizers

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

If pregnant or breast-feeding, ask a health professional before use.

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.

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.

STORAGE AND HANDLING

Other information

Store at 15°- 30°C (59°- 86°F)

INACTIVE INGREDIENT

Inactive ingredients

Cherry Flavor, Citric Acid, FD&C Red No. 40, Glycerin, Propylene Glycol, Purified Water, Sodium Citate, Sodium Saccharin, Sorbitol.

QUESTIONS

Questions? Comments?

Call 1-888-206-5525

Z-Tuss AC 118mL

INGREDIENTS AND APPEARANCE

Z-TUSS  AC
chlorpheniramine maleate, codeine phosphate liquid

Product 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	09/01/2019
2	NDC: 58407-920-10	10 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/27/2011	09/30/2013
3	NDC: 58407-920-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2019

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)

Establishment
Name	Address	ID/FEI	Business Operations
Woodfield Pharmaceuticals, LLC		079398730	manufacture(58407-920)