PALAGRIP- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid

Palagrip by

Drug Labeling and Warnings

Palagrip by is a Otc medication manufactured, distributed, or labeled by All Pharma, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Acvtive ingredients: (in 10 ml)              Purpose

Acetaminophen 200 mg ............................. Analgesic

Dextromethorphan HBr 13.33 mg ................... Cough Suppressant

Guaifenesin 200 mg ................................... Expectorant

Phenylephrine HCl 5 mg ............................. Decongestant

PURPOSE

Purpose

Analgesic

Cough Suppressant

Expectorant

Decongestant

INDICATIONS & USAGE

Uses

• For temporary relief of bronchial and nasal congestion
• Help loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make cough more productive.
• Teporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold

WARNINGS

Warnings

Do not exceed recommended dosage

Liver warning: This product contains Acetaminophen. Sever liver damage may occur if

• Adult takes more than 6 doses in 24 hours, which is the maximum daily amount
• Child takes more than 5 doses in 24 hours
• Taken with other drugs containing Acetaminophen
• Adult has 3 or more alcoholic drinks everyday while using this product
• Do not give to children under 3 years of age or use for more than 10 days unless directed by a physician

DO NOT USE

Do not use

• If you are now taking a prescription monoamine oxidase inhibitor (MAOI)( certain drugs for depression , psychiatric conditions, or Parkinson’s disease) or for 2 weeks after stopping the MAOI drug.
• if you do not know if your prescription drug contains on MAOI ask your doctor or pharmacist before taking this product
• if you have a chronic pulmonary disease or shortness of breath unless directed by a doctor
• avoid alcoholic beverages while you are taking this product
• do not use with any other drug containing Acetaminophen (prescirption or nonprescription). If you are not sure whether a drug contains Acetaminophen, ask a doctor or a pharmacist.

Ask the doctor before use if you have

• cough that occurs with too much phlegm (mucus)
• cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema
• heart disease, high blood pressure, thyroid disease, or difficulty in urination due to the enlargement of prostate gland.
• The user has liver disease
• The user is taking the blood thinning drug Warfarin.

STOP USE

Stop use and ask the doctor if

• Nervoisness, dizziness or sleeplessness occurs.
• Cough persists for more than 1 week, tends to recur, or accompanied by fever, rash or persistent headache. A persistent cough may be sign of a serious condition

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

Directions

• Do not take more than 6 doses in any 24-hour period

Age                                                                        Dose

Adults and children 12 years and over           10 mL (2 tsps) every 6 hours

Children 6 to under 12 years of age.               5 mL (1 tsps) every 6 hours

Children under 6 years of age                       Do not use

INACTIVE INGREDIENT

Inactive ingredients

Aloe vera, citric acid, disodium EDTA, FD&C Red #40, hydroxyethyl cellulose, natural strawberry flavor, propylene glycol, water, sodium benzoate, sorbitol 70%, sucralose

Palagrip (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID

INGREDIENTS AND APPEARANCE

PALAGRIP 
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53149-2001
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	250 mg  in 10 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	13.33 mg  in 10 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg  in 10 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA WHOLE (UNII: KIZ4X2EHYX)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C RED NO. 40 (UNII: WZB9127XOA)
HYDROXYMETHYL CELLULOSE (UNII: 273FM27VK1)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53149-2001-6	1 in 1 BOX	01/01/2019
1		177 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	01/01/2019

Labeler - All Pharma, LLC (078572520)

Establishment
Name	Address	ID/FEI	Business Operations
All Pharma, LLC		078572520	MANUFACTURE(53149-2001)