GUAIATUSSIN AC - codeine phosphate and guaifenesin liquid
Hi-Tech Pharmacal Co., Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active ingredients (in each 5mL teaspoonful)

Codeine Phosphate, USP 10 mg

Guaifenesin, USP 100 mg

Purposes

Cough Suppressant

Expectorant

Use

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

Warnings

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 for 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 preparation 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 teaspoonful
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 store 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 1-800-262-9010, 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.

REV. 087:00 3/10

Package/Label Principal Display Panel

NDC 50383-087-16

Guaiatussin AC

Sugar-Free

Expectorant
Cough Suppressant

Each teaspoonful (5 mL) contains

Guaifenesin...............................100 mg

Codeine Phosphate..................10 mg

Alcohol.......................................3.5 % v/v

Hi-Tech Pharmacal Co., Inc.

Amityville, NY 11701

16 fl oz (473 mL)

GUAIATUSSIN AC
guaifenesin and codeine phosphate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50383-087
Route of Administration	ORAL	DEA Schedule	CV

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CODEINE PHOSPHATE (CODEINE)	CODEINE PHOSPHATE	10 mg in 5 mL
GUAIFENESIN (GUAIFENESIN)	GUAIFENESIN	100 mg in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL
CARAMEL
ANHYDROUS CITRIC ACID
FD&C RED NO. 40
GLYCERIN
WATER
SACCHARIN SODIUM
SODIUM BENZOATE
SORBITOL
POLYETHYLENE GLYCOL 4000

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY (artificial cherry flavor)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:50383-087-16	473 mL in 1 BOTTLE	None
2	NDC:50383-087-04	118 mL in 1 BOTTLE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	09/08/2010

Labeler - Hi-Tech Pharmacal Co., Inc. (101196749)

Establishment
Name	Address	ID/FEI	Operations
Hi-Tech Pharmacal Co., Inc.		101196749	MANUFACTURE

Revised: 09/2011 Hi-Tech Pharmacal Co., Inc.