Travel Savvy Non-aspirin

Travel Savvy Non-aspirin
SPL v9
SPL
SPL Set ID 6ab08633-5d5a-42b2-e053-2991aa0ab41a
Route
ORAL
Published
Effective Date 2016-05-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg)
Inactive Ingredients
Starch, Corn Stearic Acid Titanium Dioxide Hypromelloses Polyethylene Glycol, Unspecified Povidone Sodium Starch Glycolate Type A Potato Cellulose, Microcrystalline Maltodextrin

Identifiers & Packaging

Pill Appearance
Imprint: FR;2 Shape: round Color: white Size: 10 mm Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-10-13 Until 2023-06-01

Description

Acetaminophen 325 mg

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer

Description

Acetaminophen 325 mg

Uses

For the temporary relief of minor aches and pains associated with

  • headache
  • common cold
  • muscular aches
  • toothache
  • minor arthritis pain
  • menstrual cramps

For the reduction of fever.

Warnings

Liver warning:

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

  • more than 12 tablets 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.

Directions
  • do not use more than directed

Adults and children: (12 years and older)

Take 2 tablets every 4 to 6 hours as needed. Do not take more than 12 tablets in 24 hours.

Children under 12 years:

Do not give to children under 12 years of age.

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
  • for more than 3 days for fever unless directed by a doctor
Active Ingredient

Acetaminophen 325 mg

Other Information
  • store at room temperature 59°-86°F (15°-30°C)
  • tamper-evident sealed packets
  • do not use any opened or torn packets
Inactive Ingredients

corn starch, hypromellose, maltodextrin*, microcrystalline cellulose*, polyethylene glycol, povidone*, pregelatinized starch*, sodium starch glycolate*, stearic acid, titanium dioxide*

* may contain

Questions Or Comments?

1-800-323-1319

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

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

Stop Using and Ask A Doctor If

  • symptoms do not improve
  • new symptoms occur
  • pain or fever persists or gets worse
  • redness or swelling is present
Travel Savvy Non Aspirin Label

BTravelSavvy.com

Travel Savvy

Non-Aspirin

Pain Reliever

Fever Reducer

Temporarily reduces fever

and relieves minor aches

and pains.

1000

Tablets

(500 x 2)

Ask A Doctor Before Use If You Have
  • liver disease
Ask A Doctor Or Pharmacist Before Use If
  • you are taking the blood thinning drug warfarin

Structured Label Content

Uses

For the temporary relief of minor aches and pains associated with

  • headache
  • common cold
  • muscular aches
  • toothache
  • minor arthritis pain
  • menstrual cramps

For the reduction of fever.

Purpose

Pain reliever/fever reducer

Warnings

Liver warning:

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

  • more than 12 tablets 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.

Directions
  • do not use more than directed

Adults and children: (12 years and older)

Take 2 tablets every 4 to 6 hours as needed. Do not take more than 12 tablets in 24 hours.

Children under 12 years:

Do not give to children under 12 years of age.

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.
  • for more than 10 days for pain unless directed by a doctor
  • for more than 3 days for fever unless directed by a doctor
Active Ingredient (Active ingredient)

Acetaminophen 325 mg

Other Information (Other information)
  • store at room temperature 59°-86°F (15°-30°C)
  • tamper-evident sealed packets
  • do not use any opened or torn packets
Inactive Ingredients (Inactive ingredients)

corn starch, hypromellose, maltodextrin*, microcrystalline cellulose*, polyethylene glycol, povidone*, pregelatinized starch*, sodium starch glycolate*, stearic acid, titanium dioxide*

* may contain

Questions Or Comments? (Questions or comments?)

1-800-323-1319

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

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

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

Stop Using and Ask A Doctor If (Stop using and ask a doctor if)

  • symptoms do not improve
  • new symptoms occur
  • pain or fever persists or gets worse
  • redness or swelling is present
Travel Savvy Non Aspirin Label (Travel Savvy Non-Aspirin Label)

BTravelSavvy.com

Travel Savvy

Non-Aspirin

Pain Reliever

Fever Reducer

Temporarily reduces fever

and relieves minor aches

and pains.

1000

Tablets

(500 x 2)

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • liver disease
Ask A Doctor Or Pharmacist Before Use If (Ask a doctor or pharmacist before use if)
  • you are taking the blood thinning drug warfarin

Advanced Ingredient Data


Raw Label Data

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