Medique Medicidin D/ Otis Clapp Valihist

Medique Medicidin D/ Otis Clapp Valihist
SPL v19
SPL
SPL Set ID 1f172d58-4050-424b-9743-130d8e618fe8
Route
ORAL
Published
Effective Date 2021-12-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Chlorpheniramine (2 mg) Phenylephrine (5 mg)
Inactive Ingredients
Cellulose, Microcrystalline Hypromelloses Polyethylene Glycol, Unspecified Starch, Corn Stearic Acid Crospovidone Povidone

Identifiers & Packaging

Pill Appearance
Imprint: AZ;275 Shape: round Color: white Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2008-12-30

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 4,000 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.

Indications and Usage

Uses

Temporarily relieves

  • minor aches and pains
  • headache
  • nasal congestion
  • sinus congestion and pressure
  • runny nose
  • sneezing

Temporarily

  • reduces fever
  • relieves runny nose and reduces sneezing, itching of the nose and throat and itchy, watery eyes due to hay fever
  • helps clear nasal and/or sinus passages

Dosage and Administration

Directions

  • do not use more than directed

​Adults and children (12 years and older): Take 2 tablets every 4 to 6 hours. Do not take more than 10 tablets in 24 hours.

Children under 12 years: Ask a doctor

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Overdose warning

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-12220. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 50566-9

Stop use and ask a doctor if

  • nervousness, dizziness or sleeplessness occur
  • 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
  • new symptoms occur
Section 50567-7

When using this product

  • do not exceed recommended dosage
  • excitability may occur, especially in children
  • may cause drowsiness
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • avoid alcoholic beverages
  • use caution when driving a motor vehicle or operating machinery
Section 50568-5

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers
Section 50569-3

Ask a doctor before use if you have

liver disease

thyroid disease

diabetes

high blood pressure

heart disease

glaucoma

chronic bronchitis or emphysema

difficulty in urination due to enlargement of the prostate gland

Section 50570-1

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.
  • for more than 10 days for pain unless directed by a doctor
  • if you ever had an allergic reaction to this product or any of its ingredients
  • 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.
Section 51727-6

Inactive ingredients

corn starch, crospovidone, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid

Section 53413-1

Questions or comments? 1-800-634-7680

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Purpose

Pain reliever/fever reducer

Antihistamine

Nasal decongestant

Section 55106-9

Active ingredients (in each tablet)

Acetaminophen 325 mg

Chlorpheniramine Maleate 2 mg

Phenylephrine Hydrochloride 5 mg

Section 60561-8

Other information

  • store at room temperature 59º-86ºF (15º-30ºC)
  • tamper evident sealed packets
  • do not use any opened or torn packets
  • avoid excessive heat and humidity
Principal Display Panel Medique Medicidin D Label

Medique®

Medicidin-D

Cold and Allergy Relief

This Package is for Households without Young Children.

Pull to Open

Pain Reliever/ Fever Reducer ● Acetaminophen 325mg

Antihistamine ● Chlorpheniramine Maleate 2mg

Nasal Decongestant ● Phenylephrine HCl 5mg

100Tablets

(50 x 2)

Tamper Evident Unit Dose Packets

Principal Display Panel Otis Clapp Valihist Label

Otis Clapp

Quality and Integrity Since 1840

VALIHIST ™

Decongestant-Antihistamine

Pain Reliever-Fever Reducer

Antihistamine- Decongestant

For Allergies, Colds, Runny Nose

See Warnings and Directions on Side Panel

This Package is for Households without Young Children.

Acetaminophen 325 mg,

Chlorpheniramine Maleate 2mg

Phenylephrine HCl 5 mg

Tear Out Along Perforation To Dispense

PROFESSIONAL HEALTHCARE

300 TABLETS (150 PACKETS OF 2)


Structured Label Content

Indications and Usage (34067-9)

Uses

Temporarily relieves

  • minor aches and pains
  • headache
  • nasal congestion
  • sinus congestion and pressure
  • runny nose
  • sneezing

Temporarily

  • reduces fever
  • relieves runny nose and reduces sneezing, itching of the nose and throat and itchy, watery eyes due to hay fever
  • helps clear nasal and/or sinus passages

Dosage and Administration (34068-7)

Directions

  • do not use more than directed

​Adults and children (12 years and older): Take 2 tablets every 4 to 6 hours. Do not take more than 10 tablets in 24 hours.

Children under 12 years: Ask a doctor

Warnings and Precautions (34071-1)

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 4,000 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.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Overdose warning

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-12220. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • nervousness, dizziness or sleeplessness occur
  • 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
  • new symptoms occur
Section 50567-7 (50567-7)

When using this product

  • do not exceed recommended dosage
  • excitability may occur, especially in children
  • may cause drowsiness
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • avoid alcoholic beverages
  • use caution when driving a motor vehicle or operating machinery
Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers
Section 50569-3 (50569-3)

Ask a doctor before use if you have

liver disease

thyroid disease

diabetes

high blood pressure

heart disease

glaucoma

chronic bronchitis or emphysema

difficulty in urination due to enlargement of the prostate gland

Section 50570-1 (50570-1)

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.
  • for more than 10 days for pain unless directed by a doctor
  • if you ever had an allergic reaction to this product or any of its ingredients
  • 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.
Section 51727-6 (51727-6)

Inactive ingredients

corn starch, crospovidone, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid

Section 53413-1 (53413-1)

Questions or comments? 1-800-634-7680

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Purpose

Pain reliever/fever reducer

Antihistamine

Nasal decongestant

Section 55106-9 (55106-9)

Active ingredients (in each tablet)

Acetaminophen 325 mg

Chlorpheniramine Maleate 2 mg

Phenylephrine Hydrochloride 5 mg

Section 60561-8 (60561-8)

Other information

  • store at room temperature 59º-86ºF (15º-30ºC)
  • tamper evident sealed packets
  • do not use any opened or torn packets
  • avoid excessive heat and humidity
Principal Display Panel Medique Medicidin D Label (Principal Display Panel - Medique Medicidin D Label)

Medique®

Medicidin-D

Cold and Allergy Relief

This Package is for Households without Young Children.

Pull to Open

Pain Reliever/ Fever Reducer ● Acetaminophen 325mg

Antihistamine ● Chlorpheniramine Maleate 2mg

Nasal Decongestant ● Phenylephrine HCl 5mg

100Tablets

(50 x 2)

Tamper Evident Unit Dose Packets

Principal Display Panel Otis Clapp Valihist Label (Principal Display Panel - Otis Clapp Valihist Label)

Otis Clapp

Quality and Integrity Since 1840

VALIHIST ™

Decongestant-Antihistamine

Pain Reliever-Fever Reducer

Antihistamine- Decongestant

For Allergies, Colds, Runny Nose

See Warnings and Directions on Side Panel

This Package is for Households without Young Children.

Acetaminophen 325 mg,

Chlorpheniramine Maleate 2mg

Phenylephrine HCl 5 mg

Tear Out Along Perforation To Dispense

PROFESSIONAL HEALTHCARE

300 TABLETS (150 PACKETS OF 2)


Advanced Ingredient Data


Raw Label Data

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