REGULAR STRENGTH PAIN RELIEF- acetaminophen tablet

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

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Active ingredient:
Acetaminophen 325 mg
Available from:
REMEDYREPACK INC.
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Pain Reliever/Fever Reducer - temporarily relieves minor aches and pains - temporarily reduces fever
Authorization status:
OTC monograph not final
Authorization number:
70518-0650-0

REGULAR STRENGTH PAIN RELIEF- acetaminophen tablet

REMEDYREPACK INC.

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.

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Active Ingredients

Acetaminophen 325 mg

Purpos e

Pain Reliever/Fever Reducer

Us es

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 12 tablets 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

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.

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 symptom 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.

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. Quick medical attention is critical for

adults as well as for children even if you do not notice any signs or symptoms.

Keep out of reach of children.

Directions

do not take more than directed

adults and children 12 years and over: take 2 tablets every 4-6 hours, as needed; not more than 12

tablets in 24 hours

children under 12 years: ask a doctor

Other Information

TAMPER EVIDENT: Do not use if imprinted seal under cap is missing or broken.

store at 20 C-25 C (68 F-77 F)

for institutional use only

Inactive Ingredients

povidone, sodium starch glycolate, starch stearic acid. May also contain: crospovidone, methylparaben

and probylparaben

DRUG: Regular Strength Pain Relief

GENERIC: Acetaminophen

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 70518-0650-0

COLOR: white

SHAPE: ROUND

SCORE: Two even pieces

SIZE: 10 mm

IMPRINT: M2A357344

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

Acetaminophen 325mg in 1

INACTIVE INGREDIENT(S):

CROSPOVIDONE

METHYLPARABEN

POVIDONE

PROPYLPARABEN

SODIUM STARCH GLYCOLATE TYPE A POTATO

STARCH, CORN

STEARIC ACID

REGULAR STRENGTH PAIN RELIEF

acetaminophen tablet

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:70 518 -0 6 50 (NDC:578 9 6 -10 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

325 mg

Inactive Ingredients

Ingredient Name

Stre ng th

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

SO DIUM STARCH GLYCO LATE TYPE A PO TATO (UNII: 58 56 J3G2A2)

STARCH, CO RN (UNII: O8 232NY3SJ)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

CRO SPO VIDO NE (UNII: 6 8 40 19 6 0 MK)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

REMEDYREPACK INC.

Product Characteristics

Color

white (WHITE)

S core

2 pieces

S hap e

ROUND (Ro und)

S iz e

10 mm

Flavor

Imprint Code

M2A357344

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date Marketing End Date

1

NDC:70 518 -0 6 50 -

30 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n

Pro duc t

0 7/28 /20 17

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 7/28 /20 17

Labeler -

REMEDYREPACK INC. (829572556)

Revised: 5/2019

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