FDA Label for Contac Cold Flu Day Night
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS(IN EACH CAPLET) (DAY)
- PURPOSES (DAY)
- USES (DAY)
- WARNINGS (DAY)
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS (DAY)
- OTHER INFORMATION (DAY)
- INACTIVE INGREDIENTS (DAY)
- QUESTIONS OR COMMENTS? (DAY)
- ACTIVE INGREDIENTS (IN EACH CAPLET) (NIGHT)
- PURPOSES (NIGHT)
- USES (NIGHT)
- WARNINGS (NIGHT)
- DIRECTIONS (NIGHT)
- OTHER INFORMATION (NIGHT)
- INACTIVE INGREDIENTS (NIGHT)
- QUESTIONS OR COMMENTS? (NIGHT)
- OTHER
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Contac Cold Flu Day Night Product Label
The following document was submitted to the FDA by the labeler of this product Vespyr Brands, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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.
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.
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 • trouble urinating due to disease an enlarged prostate gland
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
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.
Ask a doctor or pharmacist before use if you are
• taking the blood thinning drug warfarin
• taking sedatives or tranquilizers
Otc - When Using
When using this product do not exceed recommended dosage.
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
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.
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.
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
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.
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
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.
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
Other
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
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