Palagrip

Manufacturer
All Pharma, LLC
Effective date
2019-06-14
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:47:38

Label at a glance#

ProductPalagrip
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

Purpose

Analgesic

Cough Suppressant

Expectorant

Decongestant

INDICATIONS & USAGE SECTION

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 SECTION

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

OTC - DO NOT USE SECTION

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.

OTC - STOP USE SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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 SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1790651acetaminophen 250 MG / dextromethorphan HBr 13.33 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 10 mL Oral SolutionPSN3
1790651acetaminophen 25 MG/ML / dextromethorphan hydrobromide 1.33 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCD3
1790651acetaminophen 250 MG / dextromethorphan HBr 13.33 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG per 10 ML Oral SolutionSY3
1790651acetaminophen 500 MG / dextromethorphan HBr 26.66 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 20 ML Oral SolutionSY3
1790651APAP 25 MG/ML / Dextromethorphan Hydrobromide 1.33 MG/ML / Guaifenesin 20 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral SolutionSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53149-2001-62023-07-28C16284748780-10191ceaa-6311-198a-e063-dbdaa90aec3e2522df3b-a599-4bab-b7cc-315f40f7cca4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53149-2001-6Palagrip1 in 1 BOXLIQUID13
53149-2001-6Palagrip177 mL in 1 BOTTLELIQUID1773

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53149-2001PALAGRIP (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ALL PHARMA, LLC]3Legacy NDC, 2 package rows20220127_2522df3b-a599-4bab-b7cc-315f40f7cca4.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53149-200153149-2001-6

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
2b8521e4-3009-4212-bc2d-2303211891252522df3b-a599-4bab-b7cc-315f40f7cca42019-06-14WarningsExact identifier
spl id: 2b8521e4-3009-4212-bc2d-230321189125
spl set id: 2522df3b-a599-4bab-b7cc-315f40f7cca4

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.