L-Oral COLD AND FLU RELIEF Syrup

Manufacturer
GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED
Effective date
2021-03-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:45:45

Label at a glance#

ProductL-Oral COLD AND FLU RELIEF Syrup
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure10 sections

Indications and 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

Dosage and administration

• 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

Storage and handling

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

Label contents#

Full prescribing information#

ACTIVE INGREDIENT (IN EACH 5 ML)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg

PURPOSE

OTC - PURPOSE SECTION

Pain reliever/fever reducer
Cough suppressant
Nasal decongestant

USES

INDICATIONS & USAGE SECTION

• 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

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

• 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

STORAGE AND HANDLING SECTION

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

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

√ 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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Loral27-5Loral27-5

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73921-027-042023-02-08C16284748780-1f386c649-ad95-0266-e053-dadaa90a7c1aL-Oral COLD & FLU RELIEF SYRUP
73921-027-042023-01-30C16284748780-1f386c649-ad95-0266-e053-dadaa90a7c1aL-Oral COLD & FLU RELIEF SYRUP

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73921-02773921-027-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 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
f42bf796-2ffd-7224-e053-2995a90a7f5ad38cd1fb-7dec-4860-a73a-316c982a4c5b2023-02-08WarningsExact identifier
spl set id: d38cd1fb-7dec-4860-a73a-316c982a4c5b

Reported adverse events (FAERS/openFDA)#

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