Label: GUAIATUSSIN AC SUGAR FREE- guaifenesin and codeine phosphate liquid
50383-087-10, 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 October 5, 2020
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- Active ingredients (in each 5 mL teaspoonful)
- Keep Out of Reach of Children
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
- 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
children 6 to under 12 years of age
children under 6 years of age
Consult a doctor
- Other information
- Inactive Ingredients
- Questions or comments?
- Package/Label Principal Display Panel
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. (117696873) Registrant - Akorn Operating Company LLC (117693100) Establishment Name Address ID/FEI Business Operations Hi-Tech Pharmacal Co., Inc. 117696873 MANUFACTURE(50383-087) , ANALYSIS(50383-087) , PACK(50383-087)