Drug Facts

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

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 Drug	M012	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
3	NDC:0121-1775-40	4 in 1 CASE	01/10/2024
3		10 in 1 TRAY
3	NDC:0121-1775-05	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 Drug	M012	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
2	NDC:0121-1550-40	4 in 1 CASE	01/10/2024
2		10 in 1 TRAY
2	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 Drug	M012	10/01/2006

Labeler - PAI Holdings, LLC (044940096)

Name	Address	ID/FEI	Business Operations
Establishment
PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma		097630693	manufacture(0121-0775, 0121-1775, 0121-1550)

Guaifenesin and Codeine Phosphate

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