FDA.reportPublic FDA data

Cold and Sore Throat

Manufacturer
Cellchem Pharmaceuticals Inc | Laboratoires Confab Inc
Effective date
2022-11-28
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:45:54

Label at a glance#

ProductCold and Sore Throat
Active ingredientACETAMINOPHEN, PHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

• Temporarily relieves these symptoms due to cold: o minor aches and pains  o minor sore throat pain o headache o nasal  congestion • Temporarily reduces fever • Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:  o runny nose  o sneezing  o itchy nose and throat  o itchy, watery eyes

Dosage and administration

• do not use more than directed • take every 4 hours, while symptoms persist. Do not take more than 6 packets in 24 hours unless directed by a doctor. Age Dose adults and children 12 years and over one packet children under 12 years do not use • dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes. • if using a microwave, add contents of one packet to 8 oz....

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients (in each packet)                                                Purpose

Acetaminophen 325 mg...................................................Pain reliever/Fever reducer

Pheniramine maleate 20 mg................................................Antihistamine

Phenylephrine Hydrochloride 10 mg......................................Nasal decongestant

Uses

OTC - PURPOSE SECTION

  • Temporarily relieves these symptoms due to cold:
    • minor aches and pains 
    • minor sore throat pain
    • headache
    • nasal  congestion
  • Temporarily reduces fever
  • Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 
    • runny nose 
    • sneezing 
    • itchy nose and throat 
    • itchy, watery eyes

INDICATIONS & USAGE SECTION

Relives: 

  • Nasal congestion
  • Body aches
  • Headache
  • Runny nose
  • Sore throat pain
  • Fever

Warnings

WARNINGS SECTION

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 6 packets in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 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

OTC - DO NOT USE SECTION

  • in children under 12 years of age
  • if you are allergic to acetaminophen
  • with any other drug containing acetaminophen (prescription and non-prescription). If you are not sure whether a drug contains  cetaminophen, 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 a MAOI, ask a doctor or pharmacist before taking this product.

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor before use if you have

  • liver disease
  • heart disease 
  • high blood pressure 
  • thyroid disease
  • diabetes 
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema, asthma, or chronic bronchitis
  • a sodium restricted diet.

Ask a doctor or pharmacist before use if you are

  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

When using this product

OTC - WHEN USING SECTION

  • do not exceed recommended dosage
  • avoid alcoholic drinks
  • may cause drowsiness 
  • alcohol, sedatives, and tranquilizers may increase drowsiness 
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • nervousness, dizziness, or sleeplessness occurs 
  • pain or nasal congestion gets worse or lasts more than 7 days 
  • fever gets worse or lasts more than 3 days 
  • new symptoms occur
  • redness or swelling is present These could be signs of a serious condition.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

WARNINGS SECTION

READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE.

KEEP CARTON FOR REFERENCE.

DO NOT DISCARD

DO NOT USE IF SEALED PACKET IS TORN OR BROKEN

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not use more than directed
  • take every 4 hours, while symptoms persist.

Do not take more than 6 packets in 24 hours unless directed by a doctor.

Age

Dose

adults and children 12 years and over

one packet

children under 12 years

do not use

  • dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.
  • if using a microwave, add contents of one packet to 8 oz. of cool water; stir briskly before and after heating. Do not overheat.

SPL UNCLASSIFIED SECTION

Other Information

  • each packet contains: sodium 70 mg
  • store at controlled room temperature 20-25°C (68 -77°F). Protect from heat and moisture.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Citric acid, D&C Yellow 10, Ethylcellulose, FD&C Red 40, Flavor, Microcrystalline cellulose, Povidone, Silicon dioxide, Sodium citrate, Starch, Sugar and Vitamin C

Questions, Comments or Adverse Reactions? 

OTC - QUESTIONS SECTION

You may report serious side effects to: +1 844-481-8884
Serious side effects can also be reported to: drugsafety@cellchempharma.ca

Distributed by:
CellChem Pharmaceuticals Inc.
Unit 1, 30 Concourse Gate
Nepean, Ontario K2E 7V7

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

cartonlabel
cartonlabel
pouch
pouch

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
73147-317373147-3173-6

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
PHENIRAMINE MALEATENYW905655BACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
FD&C RED NO. 40WZB9127XOAIACT
ETHYLCELLULOSE, UNSPECIFIED7Z8S9VYZ4BIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
STARCH, CORNO8232NY3SJIACT
RAW SUGAR8M707QY5GHIACT
ASCORBIC ACIDPQ6CK8PD0RIACT

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
6d883fc7-59bc-4f76-837c-89c865906bef6c2d9335-34ac-460f-89c7-3a90cfc1301c2022-11-28WarningsExact identifier
spl id: 6d883fc7-59bc-4f76-837c-89c865906bef
spl set id: 6c2d9335-34ac-460f-89c7-3a90cfc1301c

Reported adverse events (FAERS/openFDA)#

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