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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Drug Facts

Active ingredients (in each 5mL teaspoonful)

Codeine Phosphate, USP 10 mg

Guaifenesin, USP 100 mg

Purposes

Cough Suppressant

Expectorant

Use

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

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

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. 087:01 9/11

Package/Label Principal Display Panel

Image of Container Label

NDC 50383-087-16

Guaiatussin AC

Sugar-Free

CV

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 (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
2 NDC:50383-087-04 118 mL in 1 BOTTLE
3 NDC:50383-087-07 10 in 1 CASE
3 10 in 1 TRAY
3 NDC:50383-087-05 5 mL in 1 CUP, UNIT-DOSE
4 NDC:50383-087-12 10 in 1 CASE
4 10 in 1 TRAY
4 NDC:50383-087-10 10 mL in 1 CUP, UNIT-DOSE
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)

Revised: 11/2013
Document Id: a3f9be67-29e5-4038-bfc4-150d3a339199
Set id: b920eba2-27f2-402c-a7c9-d0988977965c
Version: 4
Effective Time: 20131112
 
Hi-Tech Pharmacal Co., Inc.