OTC Medication Information: Regular Strength Pain Reliever

REGULAR STRENGTH PAIN RELIEVER- acetaminophen tablet
Healthlife of USA

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active Ingredient (In each tablet)

Acetaminophen 325mg

Purpose

Pain reliever/ Fever reducer

Uses

Temporarily relieves minor aches and pains due to:

  • headache
  • muscular aches
  • backache
  • minor pain of arthritis
  • the common cold
  • toothache
  • temporarily reduces fever
  • premenstrual and menstrual cramps

Warnings

Liver Warning:

This product contains acetaminophen. The maximum daily dose of this product is 9 tablets (2925 mg) in 24 hours. Severe liver damage may occur if you take:

  • more than 3000mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks everyday while using this product

Allergy alert:

Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If skin reaction occurs; stop use and seek medical help right away.

Do not use

  • with any other drug containing acetaminophen (prescription or not prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if you are allergic to acetaminophen or any of the inactive ingredients in this product.

Ask doctor before use if you have

liver disease

Ask your doctor or pharmacist before use if you are

taking the blood thinning drug warfarin

Stop use and ask a doctor if:

  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present

These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

Overdose warning:

Taking more than recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. 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 tablets every 4 to 6 hours while symptoms last
  • do not take more than 9 tablets in 24 hours period
  • do not use for more than 10 days unless directed by doctor

Children 6 to 12 years: take 1 tablet every 4 to 6 hours while symptoms last

  • do not use more than 5 tablets in 24 hours period
  • children under 6 years ask doctor.

Other Information

  • store at controlled room temperature 20-25°C (68-77°F)
  • read all product information before using
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Inactive ingredients

Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Pregelatinized Starch, Polyethylene Glycol, Polyvinyl Pyrolidone, Stearic acid, Talc, Titanium Dioxide.

Questions or comments?

Call toll free 1-844-832-1138 Monday through Friday 9AM-5PM EST or www.healthlifeofusa.com

Principal Display Panel Regular Strength Pain Reliever Acetaminophen 325mg- Pain Reliever/ Fever Reducer 30 Tablets

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REGULAR STRENGTH PAIN RELIEVER
acetaminophen tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:69517-123
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
STARCH 1500, PREGELATINIZED
POLYETHYLENE GLYCOLS
STEARIC ACID
TALC
TITANIUM DIOXIDE
Product Characteristics
Color white Score 2 pieces
Shape ROUND Size 10mm
Flavor Imprint Code TCL340
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69517-123-30 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 12/18/2017
Labeler — Healthlife of USA (079656178)
Establishment
Name Address ID/FEI Operations
Time Cap Laboratories, Inc. 037052099 manufacture (69517-123)

Revised: 12/2017 Healthlife of USA

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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