Your browser does not support JavaScript! GUAIATUSSIN AC (GUAIFENESIN AND CODEINE PHOSPHATE) LIQUID [HI-TECH PHARMACAL CO., INC.]
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GUAIATUSSIN AC (guaifenesin and codeine phosphate) liquid
[Hi-Tech Pharmacal Co., Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL CV OTC monograph final
NOTE: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.
Drug Label Sections

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 over2 teaspoonfuls
children 6 to under 12 years of age1 teaspoonful
children under 6 years of ageConsult 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. 087:01 9/11

Package/Label Principal Display Panel

Image of Container Label

NDC 50383-087-16

Guaiatussin AC

Sugar-Free

CV

  • 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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:50383-087
Route of AdministrationORALDEA ScheduleCV    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CODEINE PHOSPHATE (CODEINE ANHYDROUS) CODEINE PHOSPHATE10 mg  in 5 mL
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL 
CARAMEL 
ANHYDROUS CITRIC ACID 
FD&C RED NO. 40 
GLYCERIN 
POLYETHYLENE GLYCOL 4000 
WATER 
SACCHARIN SODIUM 
SODIUM BENZOATE 
SORBITOL 
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRY (artificial cherry flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50383-087-16473 mL in 1 BOTTLE
2NDC:50383-087-04118 mL in 1 BOTTLE
3NDC:50383-087-0710 in 1 CASE
310 in 1 TRAY
3NDC:50383-087-055 mL in 1 CUP, UNIT-DOSE
4NDC:50383-087-1210 in 1 CASE
410 in 1 TRAY
4NDC:50383-087-1010 mL in 1 CUP, UNIT-DOSE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/08/2010
Labeler - Hi-Tech Pharmacal Co., Inc. (101196749)
Establishment
NameAddressID/FEIBusiness Operations
Hi-Tech Pharmacal Co., Inc.101196749MANUFACTURE(50383-087)

Revised: 11/2013
 
Hi-Tech Pharmacal Co., Inc.

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