CONTAC COLD FLU DAY NIGHT- acetaminophen, phenylephrine hydrochloride, chlorpheniramine maleate kit

CONTAC by

Drug Labeling and Warnings

CONTAC by is a Otc medication manufactured, distributed, or labeled by Vespyr Brands, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts (Day)

Active ingredients(in each caplet) (Day)

Acetaminophen 500 mg
Phenylephrine hydrochloride 5 mg

Purposes (Day)

Pain reliever/fever reducer
Nasal decongestant

Uses (Day)

Temporarily relieves common cold/flu symptoms:
nasal congestion headache
minor aches and pains stuffy nose
sore throat fever
sinus congestion and pressure

Warnings (Day)

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
more than 4000 mg of acetaminophen in 24 hrs, 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, occurs with or is followed by fever, headache, rash, nausea, or vomiting, ask 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.

Ask a doctor before use if you have
liver disease heart disease
diabetes high blood pressure
thyroid trouble urinating due to disease an enlarged prostate gland

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

When using this product do not exceed recommended dosage.

Stop use and ask a doctor if
pain or nasal congestion gets worse or lasts more than 7 days
fever gets worse or lasts more than 3 days
redness or swelling is present
you get nervous, dizzy, or sleepless
new symptoms occur

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 (1-800-222-1222). Quick
medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions (Day)

do not take more than directed (see overdose warning).
adults and children 12 yrs of age and over: take 2 caplets every 6 hrs as needed.
do not take more than 8 caplets in 24 hrs.
children under 12 yrs of age: ask a doctor.

Other information (Day)

store at 20°-25°C (68°-77°F)

Inactive ingredients (Day)

corn starch, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl alcohol, potassium sorbate, povidone, sodium lauryl sulfate, stearic acid, talc.

Questions or comments? (Day)

call toll-free 1-855-874-0970 (English/Spanish) weekdays

Drug Facts (Night)

Active ingredients (in each caplet) (Night)

Acetaminophen 500 mg
Chlorpheniramine maleate 2 mg
Phenylephrine hydrochloride 5 mg

Purposes (Night)

Pain reliever/fever reducer
Antihistamine
Nasal decongestant

Uses (Night)

Temporarily relieves common cold/flu symptoms:
nasal congestion sneezing headache
runny nose fever sore throat
minor aches and pains

Warnings (Night)

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
more than 4000 mg of acetaminophen 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, occurs with or is followed by fever, headache, rash, nausea, or vomiting, ask 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.

Ask a doctor before use if you have
liver disease heart disease
diabetes high blood pressure
thyroid disease glaucoma
trouble urinating due to an enlarged prostate gland
a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are
taking the blood thinning drug warfarin
taking sedatives or tranquilizers

When using this product
do not exceed recommended dosage
drowsiness may occur avoid alcoholic drinks
alcohol, sedatives, and tranquilizers may increase drowsiness effect
be careful when driving a motor vehicle or operating machinery
excitability may occur, especially in children

Stop use and ask a doctor if
pain or nasal congestion gets worse or lasts more than 7 days
fever gets worse or lasts more than 3 days
redness or swelling is present
you get nervous, dizzy, or sleepless new symptoms occur
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 (1-800-222-1222).
Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions (Night)

do not take more than directed (see overdose warning).
adults and children 12 years of age and over: take 2 caplets every 6 hours as needed.
do not take more than 8 caplets in 24 hours.
children under 12 years of age: ask a doctor.

Other information (Night)

store at 20°-25°C (68°-77°F)

Inactive ingredients (Night)

corn starch, D&C yellow No. 10 aluminum lake, FD&C yellow No. 6 aluminum lake, microcrystalline cellulose, polyethylene glycol,
polyvinyl alcohol, potassium sorbate, povidone, sodium lauryl sulfate, stearic acid, talc, titanium dioxide.

Questions or comments? (Night)

call toll-free 1-855-874-0970 (English/Spanish) M - F, 8am -5pm EST

SPL UNCLASSIFIED SECTION

NDC: 71179-025-28

CONTAC ®

COLD + FLU

DAY

Acetaminophen -

Pain reliever/Fever reducer

Phenylephrine hydrochloride -

Nasal decongestant

Head & Body Aches

Fever Sore Throat

Nasal Congestion

Sinus Pressure

16 CAPLETS

NIGHT

Acetaminophen -

Pain reliever/Fever reducer

Chlorpheniramine maleate -

Antihistamine

Phenylephrine hydrochloride -

Nasal decongestant

Head & Body Aches

Fever Sore Throat

Nasal Congestion

Sinus Pressure

Runny Nose Sneezing

12 CAPLETS

Maximum Strength

Multi-Symptom

DISTRIBUTED BY:

Vespyr Brands ®, Inc.

East Windsor NJ 08520

©2022 Vespyr Brands ®, Inc.

All rights reserved

CONTAC ® is a registered trademark of Vespyr Brands ®, Inc.

www.contac.com

Made in Canada

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CONTAC  COLD FLU DAY NIGHT
acetaminophen, phenylephrine hydrochloride, chlorpheniramine maleate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71179-025

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71179-025-28	1 in 1 BOX; Type 0: Not a Combination Product	12/01/2023

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	0 BLISTER PACK	2
Part 2	0 BLISTER PACK	1

Part 1 of 2

CONTAC  COLD FLU DAY
phenylephrine hydrochloride, acetaminophen tablet

Product Information
Item Code (Source)	NDC: 71179-024
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
STEARIC ACID (UNII: 4ELV7Z65AP)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POVIDONE (UNII: FZ989GH94E)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
STARCH, CORN (UNII: O8232NY3SJ)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
TALC (UNII: 7SEV7J4R1U)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)

Product Characteristics
Color	white	Score	no score
Shape	OVAL	Size	19mm
Flavor		Imprint Code	sun
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		8 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	12/01/2023

Part 2 of 2

CONTAC  COLD FLU NIGHT
acetaminophen, chlorpheniramine maleat, phenylephrine hydrochloride tablet

Product Information
Item Code (Source)	NDC: 71179-026
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	2 mg

Inactive Ingredients
Ingredient Name	Strength
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
STEARIC ACID (UNII: 4ELV7Z65AP)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
TALC (UNII: 7SEV7J4R1U)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
STARCH, CORN (UNII: O8232NY3SJ)
POVIDONE (UNII: FZ989GH94E)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	yellow	Score	no score
Shape	OVAL	Size	19mm
Flavor		Imprint Code	moon
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	12/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	12/01/2023

Labeler - Vespyr Brands, Inc. (118094893)