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NDC 00121-0775-04 Guaifenesin and Codeine Phosphate 10; 100 mg/5mL; mg/5mL Details

Guaifenesin and Codeine Phosphate 10; 100 mg/5mL; mg/5mL

Guaifenesin and Codeine Phosphate is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Pharmaceutical Associates, Inc.. 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: 00121-0775-04
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: 00121-0775-04
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Guaifenesin

Product Information

NDC	00121-0775
Product ID	0121-0775_e16f3d0c-f07b-3d84-e053-2a95a90a2789
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	Guaifenesin and Codeine Phosphate
Proprietary Name Suffix	n/a
Non-Proprietary Name	Guaifenesin and Codeine Phosphate
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	Pharmaceutical Associates, Inc.
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	2024-12-31

Package

Package Images

NDC 00121-0775-04 (00121077504)

Pricing Information
NDC Package Code	0121-0775-04
Billing NDC	00121077504
Package	118 mL in 1 BOTTLE (0121-0775-04)
Marketing Start Date	2006-10-01
NDC Exclude Flag	N
Price Per Unit	0.05252
Pricing Unit	ML
Effective Date	2024-02-21
NDC Description	GUAIFEN-CODEINE 100-10 MG/5 ML
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1, 5
Classification for Rate Setting	G
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL 88d0994c-4270-4408-8837-bd97510b2118 Details

SPL UNCLASSIFIED SECTION

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredients in each 5 mL (teaspoonful)	Purposes
Codeine Phosphate, USP 10 mg	Cough Suppressant
Guaifenesin, USP 100 mg	Expectorant

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 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

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 preparation 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	10 mL (2 teaspoonfuls)
children 6 to under 12 years of age	5 mL (1 teaspoonful)
children under 6 years of age	Consult a doctor

Other information

Sodium Content: 5 mg/5 mL
Tamper evident: Do not use if seal under cap is broken or missing
Keep container closed and store away from heat
Store at 20°- 25°C (68°-77°F)

Inactive ingredients

Citric acid, edetate disodium, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, flavor, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin and sorbitol.

Questions or comments?

Call 1-800-845-8210 or visit paipharma.com

Serious side effects associated with use of this product may be reported to this number.

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

NDC 0121-0775-16

Guaifenesin and Codeine

Phosphate Oral Solution USP

CV

100 mg/10 mg per 5 mL

Expectorant / Cough Suppressant

Alcohol Free / Sugar Free

Each teaspoonful (5 mL) contains:

Guaifenesin, USP 100 mg

Codeine Phosphate, USP 10 mg

Dispense in a tight, light-resistant

container with a child-resistant closure.

DO NOT ACCEPT IF SEAL

AROUND CAP IS BROKEN OR MISSING

16 fl oz (473 mL)

pai

Pharmaceutical

Associates, Inc.

Greenville, SC 29605

Principal Display Panel - 473 mL Bottle Label

PRINCIPAL DISPLAY PANEL - 5 mL Unit Dose Cup Label

Delivers 5 mL

NDC 0121-1775-05

G UAIFENESIN AND C ODEINE P HOSPHATE

O RAL S OLUTION USP CV

100 mg/10 mg per 5 mL

Expectorant / Cough Suppressant

Alcohol Free / Sugar Free

Package Not Child-Resistant

PHARMACEUTICAL ASSOCIATES, INC.

GREENVILLE, SC 29605

SEE INSERT

PRINCIPAL DISPLAY PANEL - 10 mL Unit Dose Cup Label

Delivers 10 mL

NDC 0121-1550-10

G UAIFENESIN AND C ODEINE P HOSPHATE

O RAL S OLUTION USP CV

200 mg/20 mg per 10 mL

Expectorant / Cough Suppressant

Alcohol Free / Sugar Free

Package Not Child-Resistant

PHARMACEUTICAL ASSOCIATES, INC.

GREENVILLE, SC 29605

SEE INSERT

Principal Display Panel - 10 mL Unit Dose Cup Label - 1775

INGREDIENTS AND APPEARANCE

GUAIFENESIN AND CODEINE PHOSPHATE

guaifenesin and codeine phosphate solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0121-0775
Route of Administration	ORAL	DEA Schedule	CV

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg in 5 mL
CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J)	CODEINE PHOSPHATE	10 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
SODIUM CITRATE (UNII: 1Q73Q2JULR)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GLYCERIN (UNII: PDC6A3C0OX)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	red	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0121-0775-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2006
2	NDC:0121-0775-08	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2006
3	NDC:0121-0775-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2006

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	10/01/2006

GUAIFENESIN AND CODEINE PHOSPHATE

guaifenesin and codeine phosphate solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0121-1775
Route of Administration	ORAL	DEA Schedule	CV

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg in 5 mL
CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J)	CODEINE PHOSPHATE	10 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
SODIUM CITRATE (UNII: 1Q73Q2JULR)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GLYCERIN (UNII: PDC6A3C0OX)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	red	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0121-1775-00	10 in 1 CASE	10/01/2006
1		10 in 1 TRAY
1	NDC:0121-1775-05	5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
2	NDC:0121-1775-10	10 in 1 CASE	10/01/2006
2		10 in 1 TRAY
2		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	10/01/2006

GUAIFENESIN AND CODEINE PHOSPHATE

guaifenesin and codeine phosphate solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0121-1550
Route of Administration	ORAL	DEA Schedule	CV

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg in 10 mL
CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J)	CODEINE PHOSPHATE	20 mg in 10 mL

Ingredient Name	Strength
Inactive Ingredients
SODIUM CITRATE (UNII: 1Q73Q2JULR)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GLYCERIN (UNII: PDC6A3C0OX)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	red	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0121-1550-00	10 in 1 CASE	10/01/2006
1		10 in 1 TRAY
1	NDC:0121-1550-10	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	10/01/2006

Labeler - Pharmaceutical Associates, Inc. (044940096)

Name	Address	ID/FEI	Business Operations
Establishment
Pharmaceutical Associates, Inc.		097630693	manufacture(0121-0775, 0121-1550, 0121-1775)

Revised: 6/2022

Document Id: e16f3d0c-f07b-3d84-e053-2a95a90a2789

Set id: 88d0994c-4270-4408-8837-bd97510b2118

Version: 9

Effective Time: 20220614

Search by Drug Name or NDC

NDC 00121-0775-04 Guaifenesin and Codeine Phosphate 10; 100 mg/5mL; mg/5mL Details

Guaifenesin and Codeine Phosphate 10; 100 mg/5mL; mg/5mL

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 00121-0775-04 (00121077504)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 88d0994c-4270-4408-8837-bd97510b2118 Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Uses

Warnings

Do not use

Ask a doctor before use if you have

Stop use and ask a doctor if

Directions

Other information

Inactive ingredients

Questions or comments?

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

PRINCIPAL DISPLAY PANEL - 5 mL Unit Dose Cup Label

PRINCIPAL DISPLAY PANEL - 10 mL Unit Dose Cup Label

INGREDIENTS AND APPEARANCE

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