L-Oral PARACETAMOL Syrup

Manufacturer
GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED
Effective date
2021-03-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:47:21

Label at a glance#

ProductL-Oral PARACETAMOL Syrup
Active ingredientACETAMINOPHEN
Label structure10 sections

Indications and uses

Temporarily relieves minor aches and pains due to: • The common cold • Flu • Headache • Sore throat • Toothache • Temporarily reduces fever

Dosage and administration

• This product does not contain directions or complete warnings for adult use • Find right dose on chart. If possible, use weight to dose; otherwise, use age • mL = milliliter • If needed, repeat dose every 4 hours • Do not use more than 5 doses in 24 hours • Use enclosed dosing cup only. Do not use any other device  Weight  Age  Dose  under 24 lbs  Under 2 years  Ask a doctor  24 to 35 lbs   2 to 3 years   5mL  3...

Storage and handling

• TAMPER EVIDENT: Do not use this product if inner foil seal over mouth of the bottle is cut, torn, broken, or missing. • Store at 20°- 25°C (68° - 77°F) • This product is not the same concentration as Infants' Drops. For accurate dosing, follow the dosing instructions on this label.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Paracetamol 160 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever - Fever reducer

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Artificial flavour, Methylparaben, Propylparaben, Potassium sorbate, Citric Acid Monohydrate, Sorbitol, Propylene glycol, Sucralose, Povidone K30, Glycerin, FD&C Red #40, D&C Red #33 & Purified water.

USES

INDICATIONS & USAGE SECTION

Temporarily relieves minor aches and pains due to:
• The common cold • Flu • Headache • Sore throat • Toothache • Temporarily reduces fever

WARNINGS

WARNINGS SECTION

Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes:  • More than 5 doses in 24 hours, which is the maximum daily amount  • With other drugs containing acetaminophen

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:  • Skin reddening  • Blisters  • Rash

If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use  • With any other product containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist  • If your child is allergic to acetaminophen or any of the inactive ingredients in this product

Ask a doctor before use if your child has liver disease

Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin

When using this product, do not exceed recommended dose (see overdose warning)

Stop use and ask a doctor if
• Pain gets worse or last for more than 5 days  • Fever gets worse or last for more than 3 days  • New symptoms occur  • Redness or swelling is present
These could be signs of a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children.
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

• This product does not contain directions or complete warnings for adult use • Find right dose on chart. If possible, use weight to dose; otherwise, use age • mL = milliliter • If needed, repeat dose every 4 hours • Do not use more than 5 doses in 24 hours • Use enclosed dosing cup only. Do not use any other device

 Weight Age Dose
 under 24 lbs Under 2 years Ask a doctor
 24 to 35 lbs  2 to 3 years  5mL
 36 to 47 lbs 4 to 5 years 7.5mL
 48 to 59 lbs  6 to 8 years  10mL
 60 to 71 lbs  9 to 10 years  12.5mL
 72 to 95 lbs  11 years  15mL

OTHER INFORMATION

STORAGE AND HANDLING SECTION

• TAMPER EVIDENT: Do not use this product if inner foil seal over mouth of the bottle is cut, torn, broken, or missing.

• Store at 20°- 25°C (68° - 77°F)

• This product is not the same concentration as Infants' Drops. For accurate dosing, follow the dosing instructions on this label.

QUESTIONS OR COMMENTS?

OTC - QUESTIONS SECTION

Call toll-free 1-800-572-6632, Weekdays 7:00 AM - 5.30 PM EST.

SPL UNCLASSIFIED SECTION

√ Fever reducer - Pain reliever

√ Alcohol Free

√ Aspirin Free

Manufactured by :

Global Pharma Healthcare Pvt. Ltd.,

A-9, SIDCO Pharmaceutical Complex,

Alathur-603 110 - INDIA.

www.global-pharma.com

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Paracetamol2Paracetamol2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73921-026-042023-02-08C16284748780-1f386c649-d522-0266-e053-dadaa90a7c1aL-Oral PARACETAMOL SYRUP
73921-026-042023-01-30C16284748780-1f386c649-d522-0266-e053-dadaa90a7c1aL-Oral PARACETAMOL SYRUP

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73921-02673921-026-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 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
f42c0ea8-6233-bccf-e053-2995a90aa3142d345b38-4b89-4699-bc72-710685bee6622023-02-08WarningsExact identifier
spl set id: 2d345b38-4b89-4699-bc72-710685bee662

Reported adverse events (FAERS/openFDA)#

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