ACETAMINOPHEN by NCS HealthCare of KY, LLC dba Vangard Labs ACETAMINOPHEN tablet

ACETAMINOPHEN by

Drug Labeling and Warnings

ACETAMINOPHEN by is a Otc medication manufactured, distributed, or labeled by NCS HealthCare of KY, LLC dba Vangard Labs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

ACTIVE INGREDIENT

Active ingredient (in each tablet)
Acetaminophen 325 mg

PURPOSE

Purpose
Pain reliever/fever reducer

INDICATIONS & USAGE

Uses

• temporarily relieves minor aches and pains due to:
  • the common cold
  • headache
  • backache
  • minor pain of arthritis
  • toothache
  • muscular aches
  • premenstrual and menstrual cramps

• temporarily reduces fever

WARNINGS

Warnings
Liver Warning: This product contains acetaminophen. The maximum daily dose of this product is 10 tablets (3,250 mg) in 24 hours for adults or 5 tablets (1,625 mg) in 24 hours for children.  Severe liver damage may occur if:

• adult takes more than 4,000 mg of acetaminophen in 24 hours.
• child takes more than 5 doses in 24 hours, which is the maximum daily amount
• taken with other drugs containing acetaminophen
• adult has 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.

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.
• if you are allergic to acetaminophen or any of the inactive ingredients in this product
  

ASK DOCTOR

Ask a doctor before use if the user has liver disease

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if the user  
is taking the blood thinning drug warfarin

STOP USE

Stop use and ask a doctor if

• pain gets worse or lasts more than 10 days in adults
• pain gets worse or lasts more than 5 days in children under 12 years 
• 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.

PREGNANCY 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.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away.

(1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION

Directions  

•  do not take more than directed

 See overdose warning

adults and children 12 years and over

• take 2 tablets every 4 to 6 hours while symptoms last
• do not take more than 10 tablets in 24 hours, unless directed by a doctor
• do not use for more than 10 days unless directed by a doctor

children 6 years to under 12 years

• take 1 tablet every 4 to 6 hours while symptoms last
• do not take more than 5 tablets in 24 hours
• do not use for more than 5 days unless directed by a doctor

children under 6 years
ask a doctor

OTHER INFORMATION

Other information

• SODIUM FREE
• store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
• use by expiration date on package

INACTIVE INGREDIENT

Inactive ingredients
povidone, pregelatinized starch, sodium starch glycolate*, stearic acid
*may contain this ingredient

SPL UNCLASSIFIED SECTION

Questions or comments? call 1-877-290-4008

Manufactured by: Time-Cap Labs, Inc.,

7 Michael Avenue, Farmingdale, NY 11735

340R 1022

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0615-8398(NDC:49483-340)
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
POVIDONE (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)

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: 0615-8398-67	60 in 1 BLISTER PACK; Type 0: Not a Combination Product	04/22/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	12/15/2011

Labeler - NCS HealthCare of KY, LLC dba Vangard Labs (050052943)

Establishment
Name	Address	ID/FEI	Business Operations
NCS HealthCare of KY, LLC dba Vangard Labs		050052943	repack(0615-8398)