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NDC 17856-0273-01 Codeine-Guaifenesin 10; 100 mg/5mL; mg/5mL Details

Codeine-Guaifenesin 10; 100 mg/5mL; mg/5mL

Codeine-Guaifenesin is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by ATLANTIC BIOLOGICALS CORP.. 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: 17856-0273-01
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: 17856-0273-01
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Guaifenesin

Product Information

NDC	17856-0273
Product ID	17856-0273_ab37ecd7-9f28-420b-9300-d7f801a5926b
Associated GPIs	43997002282020
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Codeine-Guaifenesin
Proprietary Name Suffix	n/a
Non-Proprietary Name	Codeine Phosphate and Guaifenesin
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	ORAL
Active Ingredient Strength	10; 100
Active Ingredient Units	mg/5mL; mg/5mL
Substance Name	CODEINE PHOSPHATE; GUAIFENESIN
Labeler Name	ATLANTIC BIOLOGICALS CORP.
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 17856-0273-01 (17856027301)

Pricing Information	N/A
NDC Package Code	17856-0273-1
Billing NDC	17856027301
Package	72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0273-1) / 5 mL in 1 CUP, UNIT-DOSE (17856-0273-2)
Marketing Start Date	2022-11-22
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL e9705358-3522-46b3-a860-afb9141968b4 Details

SPL UNCLASSIFIED SECTION

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredients (in each 5 mL = 1 tsp)	Purpose
Codeine phosphate, USP 10 mg	Antitussive
Guaifenesin, USP 100 mg	Expectorant

Uses

temporarily relieves:
- cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritants
- your cough to help you sleep
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

Warnings

Ask your doctor before use if

you have a persistent cough, this may be a sign of a serious condition
you have a persistent cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
you have a cough that is accompanied by excessive phlegm (mucus)
you have chronic pulmonary disease or shortness of breath
giving to a child who is taking other drugs

When using this product

giving a higher dose than recommended by a doctor could result in serious side effects for your child. A special measuring device should be used to give an accurate dose of this product to children under 6 years of age.
may cause or aggravate constipation

Stop use and ask a doctor if

symptoms do not improve within 7 days, tend to recur or are accompanied by fever and rash or persistent headache. These may be symptoms of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

do not exceed 6 doses in 24 hours.

Adults and children 12 years of age and over:	2 tsp (10 mL) every 4 hours, or as directed by a doctor.
Children 6 to under 12 years of age:	1 tsp (5 mL) every 4 hours, or as directed by a doctor.
Children under 6 years of age:	Consult a doctor.

Other information

Store at controlled room temperature 15°-30°C (59°-86°F).

You may report side effects by calling 1-844-221-7294 or FDA at 1-800-FDA-1088.

Inactive ingredients

Cherry Flavor, Citric Acid Anhydrous, Glycerin, Masking Agent, Propylene Glycol, Purified Water, Sodium Benzoate, Sodium Citrate, Sorbitol Solution, Sucralose.

DISTRIBUTED BY:

ATLANTIC BIOLOGICALS CORP.

MIAMI, FL 33179

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

NDC 17856-0273-01

CODEINE-GUAIFENESIN 10-100MG - 5 ML CUP 72 ct UD

Antitussive/Expectorant

Sugar Free, Alcohol Free, Dye Free

Each 5 mL (1 teaspoonful) contains:

Codeine phosphate, USP

10 mg

Guaifenesin, USP

100 mg

(WARNING: May be habit-forming)

INGREDIENTS AND APPEARANCE

CODEINE-GUAIFENESIN

codeine phosphate and guaifenesin solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:17856-0273(NDC:69367-272)
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
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:17856-0273-1	72 in 1 BOX, UNIT-DOSE	11/22/2022
1	NDC:17856-0273-2	5 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	07/15/2020

Labeler - ATLANTIC BIOLOGICALS CORP. (047437707)

Name	Address	ID/FEI	Business Operations
Establishment
UNIT DOSE SOLUTIONS		360804194	repack(17856-0273)

Revised: 11/2022

Document Id: ab37ecd7-9f28-420b-9300-d7f801a5926b

Set id: e9705358-3522-46b3-a860-afb9141968b4

Version: 2

Effective Time: 20221122

Search by Drug Name or NDC

NDC 17856-0273-01 Codeine-Guaifenesin 10; 100 mg/5mL; mg/5mL Details

Codeine-Guaifenesin 10; 100 mg/5mL; mg/5mL

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 17856-0273-01 (17856027301)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL e9705358-3522-46b3-a860-afb9141968b4 Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Uses

Warnings

Ask your doctor before use if

When using this product

Stop use and ask a doctor if

Directions

Other information

Inactive ingredients

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

INGREDIENTS AND APPEARANCE

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