L-Oral PARACETAMOL SYRUP

L-Oral PARACETAMOL Syrup by

Drug Labeling and Warnings

L-Oral PARACETAMOL Syrup by is a Otc medication manufactured, distributed, or labeled by GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

L-ORAL PARACETAMOL SYRUP- paracetamol syrup 
GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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L-Oral PARACETAMOL SYRUP

DRUG FACTS

Active ingredient

Paracetamol 160 mg

Purpose

Pain reliever - Fever reducer

INACTIVE INGREDIENTS

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

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

WARNINGS

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.

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

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

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?

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

√ 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

Paracetamol2

L-ORAL PARACETAMOL SYRUP 
paracetamol syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 73921-026
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SORBITOL (UNII: 506T60A25R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
POVIDONE K30 (UNII: U725QWY32X)  
GLYCERIN (UNII: PDC6A3C0OX)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 73921-026-041 in 1 CARTON04/01/202102/08/2023
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34304/01/202102/08/2023
Labeler - GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED (860186917)
Establishment
NameAddressID/FEIBusiness Operations
GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED860186917manufacture(73921-026)

Revised: 2/2023
 

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