CONTAC COLD FLU DAY- phenylephrine hydrochloride, acetaminophen tablet

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

Active ingredients (in each caplet)

Acetaminophen 500 mg
Phenylephrine hydrochloride 5 mg

Purposes

Pain reliever/fever reducer
Nasal decongestant

Uses

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

Warnings

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
trouble urinating due to 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

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

store at 20°-25°C (68°-77°F)

Inactive ingredients

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

Questions or comments?

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

SPL UNCLASSIFIED SECTION

Retain outer carton for complete directions and warnings.

TAMPER-EVIDENT PACKAGING FEATURE: This product is protected in a sealed blister. Do not use if blister or printed foil is broken.

CONTAC ®

COLD + FLU DAY

Non-Drowsy Relief

DISTRIBUTED BY: Vespyr Brands®, Inc., East Windsor NJ 08520 | Made in Canada | www.contac.com
CONTAC® is a registered trademark of Vespyr Brands®, Inc. © 2022 Vespyr Brands®, Inc. | UC402408-06-05

PRINCIPAL DISPLAY PANEL

CONTACT®
COLD + FLU DAY
Phenylephrine HCl, Acetaminophen
Nasal Decongestant/Pain Reliever-Fever ReducerMaximum Strength

Multi-Symptom

Nasal Congestion

Sinus Pressure Sore Throad

Head & Body Aches Fever

8 CAPLETS

NDC: 71179-024-08

Maximum Strength

Multi-Symptom

Nasal Congestion

Sinus Pressure Sore Throad

Head & Body Aches Fever

INGREDIENTS AND APPEARANCE

CONTAC  COLD FLU DAY
phenylephrine hydrochloride, acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	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
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
STEARIC ACID (UNII: 4ELV7Z65AP)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)

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	NDC: 71179-024-08	1 in 1 BOX	11/30/2022
1		8 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 71179-024-24	3 in 1 BOX	11/30/2022
2		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	11/30/2022

Labeler - Vespyr Brands, Inc. (118094893)