GUAIATUSSIN AC SUGAR FREE- guaifenesin and codeine phosphate liquid

Guaiatussin AC by

Drug Labeling and Warnings

Guaiatussin AC by is a Otc medication manufactured, distributed, or labeled by Hi-Tech Pharmacal Co., Inc., Akorn Operating Company LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each 5 mL teaspoonful)

Codeine Phosphate, USP 10 mg

Guaifenesin, USP 100 mg

Purposes

Cough Suppressant

Expectorant

Keep Out of Reach of Children

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

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 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 1-800-262-9010, 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.

Package/Label Principal Display Panel

AKORN

NDC: 50383-087-16

Guaiatussin AC

Sugar-Free

• Expectorant
• Cough Suppresant

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

INGREDIENTS AND APPEARANCE

GUAIATUSSIN AC  SUGAR FREE
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 (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J)	CODEINE PHOSPHATE	10 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
CARAMEL (UNII: T9D99G2B1R)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50383-087-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/08/2010
2	NDC: 50383-087-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/08/2010
3	NDC: 50383-087-07	10 in 1 CASE	09/08/2010
3		10 in 1 TRAY
3	NDC: 50383-087-05	5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
4	NDC: 50383-087-12	10 in 1 CASE	09/08/2010
4		10 in 1 TRAY
4	NDC: 50383-087-10	10 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product

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	Business Operations
Hi-Tech Pharmacal Co., Inc.		101196749	MANUFACTURE(50383-087)