Active Ingredients (In Each Caplet)
Acetaminophen 500 mg
Phenylephrine hydrochloride 5 mg
Contac
FDA Label NDC 71179-024
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Vespyr Brands, Inc. for the product Contac (NDC 71179-024). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients (in each caplet), purposes, uses, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
Otc - 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.
Otc - Ask Doctor
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
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.
Otc - When Using
When using this product do not exceed recommended dosage.
Otc - Stop Use
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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdosage
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
Other
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
Package Label.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
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