Drug Facts

Active ingredient (in each softgel capsule)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

for the temporary relief of minor aches and pains associated with

the common cold
headache
toothache
muscular aches
backache
premenstrual and menstrual
the minor pain from arthritis
to reduce fever

Warnings

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

more than 8 softgel capsules in 24 hours, which is the maximum daily amount

with other drugs containing acetaminophen

3 or more alcoholic drinks every day while using this product

Acetaminophen may cause severe skin reactions. Symptoms may include: Allergy alert:

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

skin reddening
blisters
rash

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.

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.

When using this product

do not exceed recommended dosage
do not take this product for pain for more than 10 days or for fever for more than 3 days unless directed by a doctor. If pain or fever persists or gets worse, if new symptoms occur, or if redness or swelling is present, consult a doctor because these could be signs of a serious condition.
if symptoms do not improve within 7 days or are accompanied by fever, consult a doctor

Stop using and ask a doctor if

pain gets worse or lasts more than 7 days
fever gets worse or lasts more than 3 days
redness or swelling is present
new symptoms occur

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

Adults and children 12 years and over: Take 2 capsules every 6 hours while symptoms last. Do not take more than 6 capsules in 24 hours unless directed by a doctor.
Children under 12 years of age: consult a doctor.

Other information

Store at 68-77°F (20-25°C)
Avoid high humidity

Inactive ingredients

FD&C Red No. 40, gelatin, glycerin, polyethylene glycol 400, polyethylene glycol 600, silicon dioxide, titanium dioxide, water

Questions or Comments?

(346) 326-1728 Mon-Fri 8:00a.m. EST to 5:00p.m. EST

Package Labeling:

Outer Package Inner Package

FLAXENDOL EXTRA STRENGTH ACETAMINOPHEN
acetaminophen capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69377-002
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	red	Score	no score
Shape	OVAL (27)	Size	10mm
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69377-002-01	1 in 1 CARTON	07/01/2022
1		24 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M013	07/01/2022

Labeler - Gelpharma S.A. de C.V. (812773665)

Flaxendol Extra Strength Acetaminophen