Label: CONTAC COLD FLU DAY NIGHT- acetaminophen, phenylephrine hydrochloride, chlorpheniramine maleate kit
- NDC Code(s): 71179-025-28
- Packager: Vespyr Brands, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 1, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts (Day)
- Active ingredients(in each caplet) (Day)
- Purposes (Day)
- Uses (Day)
-
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 - Directions (Day)
- Other information (Day)
- Inactive ingredients (Day)
- Questions or comments? (Day)
- Drug Facts (Night)
- Active ingredients (in each caplet) (Night)
- Purposes (Night)
- Uses (Night)
-
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 bronchitisAsk a doctor or pharmacist before use if you are
• taking the blood thinning drug warfarin
• taking sedatives or tranquilizersWhen 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 - Directions (Night)
- Other information (Night)
- Inactive ingredients (Night)
- Questions or comments? (Night)
-
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
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INGREDIENTS AND APPEARANCE
CONTAC COLD FLU DAY NIGHT
acetaminophen, phenylephrine hydrochloride, chlorpheniramine maleate kitProduct 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 tabletProduct 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 tabletProduct 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)