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

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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Cold & Sore Throat

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:
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

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.

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

cartonlabel
pouch
COLD AND SORE THROAT 
acetaminophen, pheniramine maleate, phenylephrine hydrochloride powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73147-3173
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
PHENIRAMINE MALEATE (UNII: NYW905655B) (PHENIRAMINE - UNII:134FM9ZZ6M) PHENIRAMINE MALEATE20 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
STARCH, CORN (UNII: O8232NY3SJ)  
RAW SUGAR (UNII: 8M707QY5GH)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorLEMONImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73147-3173-66 in 1 BOX, UNIT-DOSE; Type 0: Not a Combination Product07/01/201912/31/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/01/201912/31/2023
Labeler - Cellchem Pharmaceuticals Inc (111518618)
Registrant - Cellchem Pharmaceuticals Inc (111518618)
Establishment
NameAddressID/FEIBusiness Operations
Laboratoires Confab Inc241754217MANUFACTURE(73147-3173)

Revised: 11/2022
 
Cellchem Pharmaceuticals Inc