ACETAMINOPHEN EXTRA STRENGTH- acetaminophen capsule

Acetaminophen by

Drug Labeling and Warnings

Acetaminophen by is a Otc medication manufactured, distributed, or labeled by Family Dollar (FAMILY WELLNESS). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each gelcap)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

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

Warnings

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

• more than 4,000 mg of acetaminophen in 24 hours 
• 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.

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 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.

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 the 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.

Direction

• do not take more than directed (see Overdose warning)
• do not take more than 6 gelcaps in any 24-hour period
• adults and children 12 years and over
  • take 2 gelcaps every 6 hours while symptoms last
  • do not take more than 10 days unless directed by a doctor
• children under 12 years: do not use

other information

• store between 15-30ºC (59-86ºF)
• avoid high humidity

Inactive ingredients

ammonium hydroxide, croscarmellose sodium, D&C red #33, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, isopropyl alcohol, n-butyl alcohol, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, purified water, shellac, silicon dioxide, stearic acid, titanium dioxide

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9 AM-5 PM EST

Principal Display Panel

COMPARE TO THE ACTIVE INGREDIENT OF TYLENOL® EXTRA STRENGTH RAPID RELEASE GELS†

EXTRA STRENGTH

Acetaminophen 500 mg

Pain Reliever/Fever Reducer

Adult

For Ages 12 Years and Over

RAPID RELEASE GELCAPS

†This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Tylenol® Extra Strength.Rapid Release Gels.

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY: MIDWOOD BRANDS, LLC

10611 MONROE RD, MATTHEWS, NC 28105

Product Label

FAMILY WELLNESS Extra Strength Pain Reliever Fever Reducer

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN  EXTRA STRENGTH
acetaminophen capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55319-541
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)
HYPROMELLOSES (UNII: 3NXW29V3WO)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE K30 (UNII: U725QWY32X)
STARCH, CORN (UNII: O8232NY3SJ)
WATER (UNII: 059QF0KO0R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
SHELLAC (UNII: 46N107B71O)
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)
AMMONIA (UNII: 5138Q19F1X)

Product Characteristics
Color	RED, GRAY, BLUE	Score	no score
Shape	CAPSULE	Size	20mm
Flavor		Imprint Code	G1G1
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55319-541-50	1 in 1 BOX	07/31/2018
1		50 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	07/31/2018

Labeler - Family Dollar (FAMILY WELLNESS) (024472631)