REGULAR STRENGTH PAIN RELIEVER- acetaminophen tablet

Regular Strength Pain Reliever by

Drug Labeling and Warnings

Regular Strength Pain Reliever by is a Otc medication manufactured, distributed, or labeled by Healthlife of USA, Time Cap Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 RelieverAcetaminophen 325mg- Pain Reliever/ Fever Reducer30 Tablets

INGREDIENTS AND APPEARANCE

REGULAR STRENGTH PAIN RELIEVER 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69517-123
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg

Inactive Ingredients
Ingredient Name	Strength
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
STARCH 1500, PREGELATINIZED (UNII: O8232NY3SJ)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white	Score	2 pieces
Shape	ROUND	Size	10mm
Flavor		Imprint Code	TCL340
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69517-123-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	12/18/2017

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	Business Operations
Time Cap Laboratories, Inc.		037052099	manufacture(69517-123)