EXTRA STRENGTH NO-PAIN- acetaminophen tablet

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)
Available from:
Safrel Pharmaceuticals, LLC.
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Pain reliever/fever reducer - temporary relieves minor aches and pains due to - the common cold - headache - backache - toothache - muscular aches - premenstrual and menstrual cramps and - temporarily reduces fever
Authorization status:
OTC monograph not final
Authorization number:
71309-001-05, 71309-001-40

EXTRA STRENGTH NO-PAIN- acetaminophen tablet

Safrel Pharmaceuticals, LLC.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Acetaminophen Extra Strength 500 mg

Active Ingredient

(in each tablet)

Acetaminophen 500mg

Purpos e

Pain reliever/fever reducer

Us es

temporary relieves minor aches and pains due to

the common cold

headache

backache

toothache

muscular aches

premenstrual and menstrual cramps and

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 have ever had an allergic reaction to this product or any of its ingredients

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 reccomended 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.

Do not exceed recommended dosage.

Directions

do not use more than directed (see overdose warning)

Adults and children 12 years of age and older:

Take 2 caplets every 6 hours while symptoms last.

Do not take more than 6 caplets in 24 hours, unless directed by a doctor

Do not use more than 10 days unless directed by a doctor.

Children under 12 years of age: Do not use this extra strength product. This will provide more than

the recommended dose (overdose) and could cause serious health problems.

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

1-844-384-3723 (Mon-Fri 9AM-5PM EST) or www.safrelpharma.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

* This product is not manufactured or distributed by McNeil-Consumer Healthcare, owner of the

registered trademark Tylenol*.

NDC 71309-001-40 40 Caplets

EXTRA STRENGTH NO-PAIN

acetaminophen tablet

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:7130 9 -0 0 1

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ACETAMINO PHEN (UNII: 36 2O9 ITL9 D) (ACETAMINOPHEN - UNII:36 2O9 ITL9 D)

ACETAMINOPHEN

50 0 mg

Inactive Ingredients

Ingredient Name

Stre ng th

STARCH, PREGELATINIZED CO RN (UNII: O8 232NY3SJ)

PO VIDO NE (UNII: FZ9 8 9 GH9 4E)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

HYPRO MELLO SES (UNII: 3NXW29 V3WO)

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

PO LYETHYLENE GLYCO L, UNSPECIFIED (UNII: 3WJQ0 SDW1A)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

TALC (UNII: 7SEV7J4R1U)

Product Characteristics

Color

white

S core

no sco re

S hap e

CAPSULE

S iz e

18 mm

Flavor

Imprint Code

Contains

Safrel Pharmaceuticals, LLC.

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:7130 9 -0 0 1-0 5

50 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 7/31/20 17

2

NDC:7130 9 -0 0 1-40

1 in 1 CARTON

0 7/31/20 17

2

40 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt343

0 7/31/20 17

Labeler -

Safrel Pharmaceuticals, LLC. (080566287)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Safrel Pharmaceuticals, LLC.

0 8 0 56 6 28 7

ma nufa c ture (7130 9 -0 0 1)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Elysium Pharmaceutical Ltd.

9 156 6 448 6

ma nufa c ture (7130 9 -0 0 1)

Revised: 10/2020

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