Acetaminophen, Caffeine, Diuretic, Pyrilamine Maleate, Antihistamine

Acetaminophen, Caffeine, Diuretic, Pyrilamine Maleate, Antihistamine
SPL v1
SPL
SPL Set ID cfc785c6-870f-45a7-86a5-d9b9de06dd8c
Route
ORAL
Published
Effective Date 2012-08-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg) Caffeine (60 mg) Pyrilamine (15 mg)
Inactive Ingredients
Carnauba Wax Croscarmellose Sodium Fd&c Blue No. 2 Hypromelloses Magnesium Stearate Cellulose, Microcrystalline Starch, Corn Propylene Glycol Shellac Titanium Dioxide Triacetin

Identifiers & Packaging

Pill Appearance
Imprint: CH Shape: capsule Color: white Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2013-05-01

Description

(in each caplet) Acetaminophen 500 mg Caffeine 60 mg Pyrilamine Maleate 15 mg

Purpose

Pain Reliever Diuretic Antihistamine


Medication Information

Purpose

Pain Reliever

Diuretic

Antihistamine

Description

(in each caplet) Acetaminophen 500 mg Caffeine 60 mg Pyrilamine Maleate 15 mg

Uses

For the temporary relief of these symptoms associated with menstrual periods:

  • Cramps
  • Bloating
  • Water-weight gain
  • Headache
  • Backache
  • Muscle aches
  • Fatigue
Warnings

SEE BOTTLE FOR ADDITIONAL WARNINGS AND PRODUCT INFORMATION.

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

  • More than 6 caplets in 24 hours, which is the maximum daily amount for this product
  • With other drug containing acetaminophen
  • 3 or more alcoholic drinks every day while using 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 have ever had an allergic reaction to this product or any of its ingredients.

Ask a doctor before use if you have:

  • Liver disease
  • Glaucoma
  • Difficulty in urination due to enlargement of the prostate gland
  • A breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are:

  • Taking the blood thinning drug warfarin
  • Taking sedatives or tranquilizers

    When using this product:

  • You may get drowsy
  • Avoid alcoholic drinks
  • Excitability may occur, especially in children
  • Alcohol, sedatives, and tranquilizers may increase drowsiness
  • Be careful when driving a motor vehicle or operating machinery
  • Limit the use of caffeine-containing medications, foods, or beverages because too much caffeine may cause nervousness, irritability, sleeplessness, and occasionally, rapid heartbeat. The recommended dose of this product contains as a cup of coffee.

    Stop use and ask a doctor if:

  • new symptoms occur
  • redness or swelling is present
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • If pregnant or breast feeding ask a health professional before use.

Directions

Do not take more than the recommended dose

  • Adults and Children 12 years and older:
  • take 2 caplets with water
  • repeat every 6 hours, as needed
  • do not exceed 6 caplets per day
  • Children under 12 years: ask a doctor.
Questions?

Call 1-855-314-1850

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Distributed by: Velocity Pharma LLC

Active Ingredient

(in each caplet)

Acetaminophen 500 mg

Caffeine 60 mg

Pyrilamine Maleate 15 mg

Other Information
  • Store at a controlled temperature between 62 and 77 degrees F
Inactive Ingredients

Carnauba wax, croscarmellose sodium, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, micro-crystalline cellulose, pregelatinized starch, propylene glycol, shellac, titanium dioxide, triacetin

Keep Out of Reach of Children.

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

Package Label.principal Display Panel

NDC: 76168-064-03 –20 COUNT

Enteric Coated to help prevent upset stomach


Structured Label Content

Uses

For the temporary relief of these symptoms associated with menstrual periods:

  • Cramps
  • Bloating
  • Water-weight gain
  • Headache
  • Backache
  • Muscle aches
  • Fatigue
Purpose

Pain Reliever

Diuretic

Antihistamine

Warnings

SEE BOTTLE FOR ADDITIONAL WARNINGS AND PRODUCT INFORMATION.

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

  • More than 6 caplets in 24 hours, which is the maximum daily amount for this product
  • With other drug containing acetaminophen
  • 3 or more alcoholic drinks every day while using 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 have ever had an allergic reaction to this product or any of its ingredients.

Ask a doctor before use if you have:

  • Liver disease
  • Glaucoma
  • Difficulty in urination due to enlargement of the prostate gland
  • A breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are:

  • Taking the blood thinning drug warfarin
  • Taking sedatives or tranquilizers

    When using this product:

  • You may get drowsy
  • Avoid alcoholic drinks
  • Excitability may occur, especially in children
  • Alcohol, sedatives, and tranquilizers may increase drowsiness
  • Be careful when driving a motor vehicle or operating machinery
  • Limit the use of caffeine-containing medications, foods, or beverages because too much caffeine may cause nervousness, irritability, sleeplessness, and occasionally, rapid heartbeat. The recommended dose of this product contains as a cup of coffee.

    Stop use and ask a doctor if:

  • new symptoms occur
  • redness or swelling is present
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • If pregnant or breast feeding ask a health professional before use.

Directions

Do not take more than the recommended dose

  • Adults and Children 12 years and older:
  • take 2 caplets with water
  • repeat every 6 hours, as needed
  • do not exceed 6 caplets per day
  • Children under 12 years: ask a doctor.
Questions?

Call 1-855-314-1850

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Distributed by: Velocity Pharma LLC

Active Ingredient

(in each caplet)

Acetaminophen 500 mg

Caffeine 60 mg

Pyrilamine Maleate 15 mg

Other Information
  • Store at a controlled temperature between 62 and 77 degrees F
Inactive Ingredients

Carnauba wax, croscarmellose sodium, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, micro-crystalline cellulose, pregelatinized starch, propylene glycol, shellac, titanium dioxide, triacetin

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

NDC: 76168-064-03 –20 COUNT

Enteric Coated to help prevent upset stomach


Advanced Ingredient Data


Raw Label Data

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