GUAIATUSSIN AC SUGAR FREE- guaifenesin and codeine phosphate liquid 
Akorn Operating Company LLC

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 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 1-800-932-5676, 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

Container Label 16 oz

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

Distributed by:

Akorn Operating Company LLC

Gurnee, IL 60031

16 fl oz (473 mL)

GUAIATUSSIN AC  SUGAR FREE
guaifenesin and codeine phosphate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50383-087
Route of AdministrationORALDEA ScheduleCV    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J) CODEINE PHOSPHATE10 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorCHERRY (artificial cherry flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50383-087-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product09/08/2010
2NDC:50383-087-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product09/08/2010
3NDC:50383-087-0710 in 1 CASE09/08/2010
310 in 1 TRAY
3NDC:50383-087-055 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
4NDC:50383-087-1210 in 1 CASE09/08/2010
410 in 1 TRAY
4NDC:50383-087-1010 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/08/2010
Labeler - Akorn Operating Company LLC (117696873)
Registrant - Akorn Operating Company LLC (117693100)
Establishment
NameAddressID/FEIBusiness Operations
Akorn Operating Company LLC117696873MANUFACTURE(50383-087) , PACK(50383-087)

Revised: 10/2022
Document Id: 487f1ce3-77d3-4390-ba6b-d9fed18c7f4d
Set id: b920eba2-27f2-402c-a7c9-d0988977965c
Version: 8
Effective Time: 20221014
 
Akorn Operating Company LLC