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NDC 50383-0087-07 Guaiatussin AC 10; 100 mg/5mL; mg/5mL Details

Guaiatussin AC 10; 100 mg/5mL; mg/5mL

Guaiatussin AC is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Akorn Operating Company LLC. The primary component is CODEINE PHOSPHATE; GUAIFENESIN.

MedlinePlus Drug Summary

Codeine is used to relieve mild to moderate pain. It is also used, usually in combination with other medications, to reduce coughing. Codeine will help relieve symptoms but will not treat the cause of symptoms or speed recovery. Codeine belongs to a class of medications called opiate (narcotic) analgesics and to a class of medications called antitussives. When codeine is used to treat pain, it works by changing the way the brain and nervous system respond to pain. When codeine is used to reduce coughing, it works by decreasing the activity in the part of the brain that causes coughing. Codeine is also available in combination with acetaminophen (Capital and Codeine, Tylenol with Codeine), aspirin, carisoprodol, and promethazine and as an ingredient in many cough and cold medications. This monograph only includes information about the use of codeine. If you are taking a codeine combination product, be sure to read information about all the ingredients in the product you are taking and ask your doctor or pharmacist for more information.

Related Packages: 50383-0087-07
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Codeine

Guaifenesin is used to relieve chest congestion. Guaifenesin may help control symptoms but does not treat the cause of symptoms or speed recovery. Guaifenesin is in a class of medications called expectorants. It works by thinning the mucus in the air passages to make it easier to cough up the mucus and clear the airways.

Related Packages: 50383-0087-07
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Guaifenesin

Product Information

NDC	50383-0087
Product ID	50383-087_487f1ce3-77d3-4390-ba6b-d9fed18c7f4d
Associated GPIs	43997002282020
GCN Sequence Number	045669
GCN Sequence Number Description	codeine phosphate/guaifenesin LIQUID 10-100MG/5 ORAL
HIC3	B4S
HIC3 Description	OPIOID ANTITUSSIVE-EXPECTORANT COMBINATION
GCN	91713
HICL Sequence Number	000206
HICL Sequence Number Description	CODEINE PHOSPHATE/GUAIFENESIN
Brand/Generic	Generic
Proprietary Name	Guaiatussin AC
Proprietary Name Suffix	Sugar Free
Non-Proprietary Name	guaifenesin and codeine phosphate
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	ORAL
Active Ingredient Strength	10; 100
Active Ingredient Units	mg/5mL; mg/5mL
Substance Name	CODEINE PHOSPHATE; GUAIFENESIN
Labeler Name	Akorn Operating Company LLC
Pharmaceutical Class	Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Full Opioid Agonists [MoA], Increased Respiratory Secretions [PE], Opioid Agonist [EPC]
DEA Schedule	CV
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2023-12-31

Package

Package Images

NDC 50383-0087-07 (50383008707)

Pricing Information	N/A
NDC Package Code	50383-087-07
Billing NDC	50383008707
Package	10 TRAY in 1 CASE (50383-087-07) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (50383-087-05)
Marketing Start Date	2010-09-08
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b920eba2-27f2-402c-a7c9-d0988977965c Details

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

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)

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	09/08/2010

Labeler - Akorn Operating Company LLC (117696873)

Registrant - Akorn Operating Company LLC (117693100)

Name	Address	ID/FEI	Business Operations
Establishment
Akorn Operating Company LLC		117696873	MANUFACTURE(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

Search by Drug Name or NDC

NDC 50383-0087-07 Guaiatussin AC 10; 100 mg/5mL; mg/5mL Details

Guaiatussin AC 10; 100 mg/5mL; mg/5mL

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 50383-0087-07 (50383008707)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL b920eba2-27f2-402c-a7c9-d0988977965c Details

Active ingredients (in each 5 mL teaspoonful)

Purposes

Keep Out of Reach of Children

Uses

Warnings

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

Stop use and ask a doctor if

If pregnant or breast-feeding

Keep Out of Reach of Children

Directions

Other information

Inactive Ingredients

Questions or comments?

Package/Label Principal Display Panel

INGREDIENTS AND APPEARANCE

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