EXTRA STRENGTH ACETAMINOPHEN- acetaminophen capsule, gelatin coated

Drug Labeling and Warnings

Drug Details [pdf]

Active ingredient (in each gelcap)

Acetaminophen 500 mg

Purpose

Pain Reliever/Fever Reducer

Uses

• temporarily relieves minor aches and pains
  
• temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen.
Severe liver damage may occur if you take:
more than 8 gelcaps (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 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.

Directions

• do not take more than directed
• adults and children 12 years and over: Take 2 gelcaps every

6 hours, as needed; not more than 6 gelcaps in 24 hours.
Do not take for more than 10 days unless directed by a doctor.

• children under 12 years: ask a doctor

Other Information

• store at 20⁰C-25⁰C (68⁰F-77⁰F). avoid high humidity

Inactive Ingredients

Croscarmellose Sodium, D and C Red 33, FD and C Blue 1, FD and C Red 40, Gelatin, Hydroxypropyl Cellulose, Hypromellose, Iron Oxide, PEG, Povidone, Propylene Glycol, Shellac Glaze, Starch, Stearic Acid, Titanium Dioxide.

Questions or comments?

1-800-540-3765

Package label

INGREDIENTS AND APPEARANCE

EXTRA STRENGTH ACETAMINOPHEN 
acetaminophen capsule, gelatin coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87438-0001
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)
GELATIN (UNII: 2G86QN327L)
HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)
HYPROMELLOSES (UNII: 3NXW29V3WO)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Product Characteristics
Color	red (red, gray and blue)	Score	no score
Shape	CAPSULE (Gelcap)	Size	19mm
Flavor		Imprint Code	L5
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87438-0001-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	05/01/2026

Labeler - Pinnacle RX LLC (136361430)

Registrant - Geri-Care Pharmaceutical Corp (611196254)