COLD AND SORE THROAT- acetaminophen, pheniramine maleate, phenylephrine hydrochloride powder

Cold and Sore Throat by

Drug Labeling and Warnings

Cold and Sore Throat by is a Otc medication manufactured, distributed, or labeled by Cellchem Pharmaceuticals Inc, Laboratoires Confab Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

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

• 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

Relives: 

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

Warnings

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

• 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.

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

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

When using this product

• 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

• 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.

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.

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

• 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.

INFORMATION FOR PATIENTS

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

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? 

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

INGREDIENTS AND APPEARANCE

COLD AND SORE THROAT 
acetaminophen, pheniramine maleate, phenylephrine hydrochloride powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73147-3173
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
PHENIRAMINE MALEATE (UNII: NYW905655B) (PHENIRAMINE - UNII:134FM9ZZ6M)	PHENIRAMINE MALEATE	20 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C RED NO. 40 (UNII: WZB9127XOA)
ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POVIDONE (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
STARCH, CORN (UNII: O8232NY3SJ)
RAW SUGAR (UNII: 8M707QY5GH)
ASCORBIC ACID (UNII: PQ6CK8PD0R)

Product Characteristics
Color		Score
Shape		Size
Flavor	LEMON	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73147-3173-6	6 in 1 BOX, UNIT-DOSE; Type 0: Not a Combination Product	07/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	07/01/2019

Labeler - Cellchem Pharmaceuticals Inc (111518618)

Registrant - Cellchem Pharmaceuticals Inc (111518618)

Establishment
Name	Address	ID/FEI	Business Operations
Laboratoires Confab Inc		241754217	manufacture(73147-3173)