OTC Medication Information: L-Oral COLD AND FLU RELIEF Syrup

L-ORAL COLD AND FLU RELIEF SYRUP- acetaminophen, dextromethorphan hydrobromide and phenylephrine hydrochloride 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.

DRUG FACTS

ACTIVE INGREDIENT (IN EACH 5 ML)

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg

PURPOSE

Pain reliever/fever reducer
Cough suppressant
Nasal decongestant

USES

• Temporarily relieves common cold/flu symptoms: • Nasal congestion • Cough due to minor throat and bronchial irritation • Sore throat • Headache • Minor aches and pains • Fever

WARNINGS

Liver warning: This product contains acetaminophen. Severe liver damage may occur if • Adult takes more than 4,000 mg of acetaminophen in 24 hours • Child takes more than 5 doses in 24 hours • Taken with other drugs containing acetaminophen • Adult has 3 or more alcoholic drinks every day while using this product

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 drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. • If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. • If you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have • Liver disease • Heart disease • Thyroid disease • Diabetes • High blood pressure • Trouble urinating due to an enlarged prostate gland • Cough that occurs with too much phlegm (mucus) • Persistent or chronic cough such as occurs with smoking, asthma, or emphysema

Ask a doctor or pharmacist before use if you are
Taking the blood thinning drug warfarin

When using this product do not use more than directed

Stop use and ask a doctor if • You get nervous, dizzy or sleepless • Pain, nasal congestion or cough gets worse or lasts more than 5 days (children) or 7 days (adults) • Fever gets worse or lasts more than 3 days • Redness or swelling is present • New symptoms occur • Cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.

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

Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

DIRECTIONS

• Take only as directed — see Overdose warning • Only use the dose cup provided • Do not exceed 4 doses per 24 hrs

Adults & children 12 yrs & over 30 mL every 4 hrs
Children 6 to under 12 yrs 15 mL every 4 hrs
Children 4 to under 6 yrs Ask a doctor
Children under 4 yrs Do not use

OTHER INFORMATION

• Each 15 mL contains: sodium 7 mg • Store at 20-25°C (68-77°F)

INACTIVE INGREDIENTS

Butylated hydroxyanisole, Edetate disodium, FD&C yellow no. 6, Flavor, Glycerin, Menthol, Monobasic sodium phosphate, Polyethylene glycol, Propylene glycol, Purified water, Saccharin sodium, Sucrose, Xanthan gum

QUESTIONS OR COMMENTS?

Call toll-free 1-800-572-6632, weekdays, 7:00 AM — 5:30 PM EST.

√ Cough Relief √ Aches √ Fever √ Sore throat √ Sneezing/Runny nose

Manufactured by :

Global Pharma Healthcare Pvt. Ltd.,

A-9, SIDCO Pharmaceutical Complex,

Alathur-603 110 — INDIA.

www.global-pharma.com

Packaging

Loral27-5
(click image for full-size original)

L-ORAL COLD AND FLU RELIEF SYRUP
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride syrup
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:73921-027
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 10 mg in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 5 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYANISOLE
EDETATE DISODIUM
FD&C YELLOW NO. 6
GLYCERIN
MENTHOL, UNSPECIFIED FORM
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM
POLYETHYLENE GLYCOL, UNSPECIFIED
PROPYLENE GLYCOL
WATER
SACCHARIN SODIUM
SUCROSE
XANTHAN GUM
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:73921-027-04 1 BOTTLE in 1 CARTON contains a BOTTLE
1 118 mL in 1 BOTTLE This package is contained within the CARTON (73921-027-04)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 04/01/2021
Labeler — GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED (860186917)
Establishment
Name Address ID/FEI Operations
GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED 860186917 manufacture (73921-027)

Revised: 03/2021 GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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