Guaifenesin And Codeine Phosphate Solution [Nucare Pharmaceuticals,inc.] -

GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [NUCARE PHARMACEUTICALS,INC.]
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NDC	68071-1350-4
Set ID	70598f87-991a-e367-e053-2a91aa0acc2f
Category	HUMAN OTC DRUG LABEL
Packager	NuCare Pharmaceuticals,Inc.
Generic Name
Product Class
Product Number
Application Number	PART341

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SPL UNCLASSIFIED SECTION

Drug Facts
ACTIVE INGREDIENT

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 -

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

INGREDIENTS AND APPEARANCE

GUAIFENESIN AND CODEINE PHOSPHATE
guaifenesin and codeine phosphate solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68071-1350(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
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
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)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
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	Marketing End Date
Packaging
1	NDC:68071-1350-4	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/06/2018

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

Labeler - NuCare Pharmaceuticals,Inc. (010632300)

Name	Address	ID/FEI	Business Operations
Establishment
NuCare Pharmaceuticals,Inc.		010632300	relabel(68071-1350)

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Medic

GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [NUCARE PHARMACEUTICALS,INC.]

Do not use

Ask a doctor before use if you have

Stop use and ask a doctor if

Related Drugs

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