Label: GUAIATUSSIN AC- guaifenesin and codeine phosphate liquid
view more50383-087-12, 50383-087-16
- Packager: Hi-Tech Pharmacal Co., Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: CV
- Marketing Status: OTC monograph final
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.
Updated November 12, 2013
If you are a consumer or patient please visit this version.
- Active ingredients (in each 5mL teaspoonful)
Codeine Phosphate, USP 10 mg
Guaifenesin, USP 100 mgClose
- 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
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
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
- 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.Close
- 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 9/11Close
- Package/Label Principal Display Panel
- Cough Suppressant
Each teaspoonful (5 mL) contains
Codeine Phosphate..................10 mg
Alcohol.......................................3.5 % v/v
Hi-Tech Pharmacal Co., Inc.
Amityville, NY 11701
16 fl oz (473 mL)Close
- INGREDIENTS AND APPEARANCE
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)