Label: CONTAC COLD AND FLU DAY- acetaminophen and phenylephrine hydrochloride tablet
- NDC Code(s): 46017-024-08, 46017-024-24, 46017-024-99
- Packager: Mylan Consumer Healthcare, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Updated January 15, 2020
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- Active ingredients for Day Formula (in each caplet)
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 4000 mg 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
If a skin reaction occurs, stop use and seek medical help right away.
Sore throat warning: If sore throat persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting, ask a doctor promptly.
DO NOT USE
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 DOCTOR
- ASK DOCTOR/PHARMACIST
- WHEN USING
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- 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
- Inactive ingredients
PRINCIPAL DISPLAY PANEL
Display Panel CONTAC Cold + Flu Day Caplets: 24 count Package
Phenylephrine HCl, Acetaminophen
Nasal Decongestant/Pain Reliever-Fever Reducer
Nasal Congestion • Sinus Pressure •Sore Throat
Head & Body Aches • Fever
TAMPER-EVIDENT PACKAGING FEATURE: This product is protected in a sealed blister. Do not use if blister or printed foil is broken.
Mylan Consumer Healthcare, Inc.
Morgantown, WV 26505 Made in Canada
CONTAC® is a registered trademark of Meda AB, a Mylan Company
© 2019 Mylan, Inc.
INGREDIENTS AND APPEARANCE
CONTAC COLD AND FLU DAY
acetaminophen and phenylephrine hydrochloride tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:46017-024 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 MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) SODIUM LAURYL SULFATE (UNII: 368GB5141J) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) POLYSORBATE 80 (UNII: 6OZP39ZG8H) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) Product Characteristics Color WHITE Score no score Shape CAPSULE Size 21mm Flavor Imprint Code MS Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:46017-024-08 1 in 1 CARTON 07/01/2011 1 NDC:46017-024-99 8 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:46017-024-24 3 in 1 CARTON 07/01/2011 2 NDC:46017-024-99 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 final part341 07/01/2011 Labeler - Mylan Consumer Healthcare, Inc. (831410522)