ACETAMINOPHEN 500MG CAFFEINE 65MG tablet

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

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Active ingredient:
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)
Available from:
Strive Pharmaceuticals Inc
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
*temporarily relieves minor aches and pains due to: - headache - muscular aches Pain reliever ; Pain reliever aid
Authorization status:
OTC monograph not final
Authorization number:
70692-110-41

ACETAMINOPHEN 500MG CAFFEINE 65MG- acetaminophen 500mg caffeine 65mg tablet

Strive Pharmaceuticals 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.

----------

Headache - Dolor de Cabeza (Acetaminophen 500mg; Caffeine 65mg)

Acetaminophen 500mg; Caffeine 65mg

colloidal silicon dioxide, croscarmellose sodium, D&C red #27, FD&C blue #2, FD&C yellow #6,

magnesium stearate, maize starch, microcrystalline cellulose, polyethylene glycol, pregalatinized

starch, polyvinyl alcohol, sodium starch glycolate, talc, titanium dioxide

take with a full glass of water

do not take more than directed

do not take more than 6 caplets in 24 hours

adults and children 12 years of age and

over

take 2 caplets every 6 hours, not more than 6 caplets in 24

hours

children under 12 years of age

ask a doctor

*temporarily relieves minor aches and pains due to:

headache

muscular aches

Liver warning:

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

more than 6 caplets in 24 hours, which is the maimum daily amount

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

Caffeine warning:

The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the

use of caffeine-containing medications, foods or beverages while takingthis product because too much

caffeine may cause nervousness, irritability, sleeplessness, and occassionally rapis heart beat.

Do not use

if you are allergic to acetaminophen

with any other drug containing acetaminophen (prescription or non prescription). 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 a 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

new symptoms occur

painful area is red or swollen

These could be signs of a serious comdition

If pregnant or breast-feeding,

ask a health professional before use

Keep out of reach of children

Overdose warning: In case of accidental overdose, get medical help or contact a Poison Control

Center right away. Prompt 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

Overdose Warning: In case of accidental overdose, get medical help or contact a Poison Control

Center right away. Prompt medical attention is critical for adults as well as for children even if you do

not notice any signs or symptoms.

Pain reliever ; Pain reliever aid

store at room temperature between 20

C - 25

C (68

F - 77

ACETAMINOPHEN 500MG CAFFEINE 65MG

acetaminophen 500mg caffeine 65mg tablet

acetaminophen 500mg caffeine 65mg tablet

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:70 6 9 2-110

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

CAFFEINE (UNII: 3G6 A5W338 E) (CAFFEINE - UNII:3G6 A5W338 E)

CAFFEINE

6 5 mg

Inactive Ingredients

Ingredient Name

Stre ng th

D&C RED NO . 2 7 (UNII: 2LRS18 5U6 K)

PO LYVINYL ALCO HO L, UNSPECIFIED (UNII: 532B59 J9 9 0 )

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

FD&C BLUE NO . 2 (UNII: L0 6 K8 R7DQK)

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

STARCH, CO RN (UNII: O8 232NY3SJ)

TALC (UNII: 7SEV7J4R1U)

SO DIUM STARCH GLYCO LATE TYPE A CO RN (UNII: AG9 B6 5PV6 B)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

FD&C YELLO W NO . 6 (UNII: H77VEI9 3A8 )

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

PO LYETHYLENE GLYCO L 4 0 0 (UNII: B6 9 78 9 4SGQ)

Product Characteristics

Color

re d

S core

no sco re

S hap e

CAPSULE

S iz e

18 mm

Flavor

Imprint Code

S777

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:70 6 9 2-110 -41

4 in 1 PACKAGE; Type 0 : No t a Co mbinatio n Pro duct

12/20 /20 18

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

12/20 /20 18

Strive Pharmaceuticals Inc

Labeler -

Strive Pharmaceuticals Inc (080028013)

Revised: 12/2018

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