TENSION HEADACHE RELIEF- acetaminophen 500mg tablet, coated

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:
Healthlife of USA
INN (International Name):
ACETAMINOPHEN
Composition:
ACETAMINOPHEN 500 mg
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Pain reliever, Pain reliever aid Temporarily relief minor aches and pains due to: - Headache - Muscular aches - with any other drug containing acetaminophen (prescription or nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure. - if you have liver disease - Any new symptoms appear - Symptoms do not get better or worsen - Painful area is red or swollen - pain gets worse or lasts for more than 10 days - fever gets worse or lasts for more than 3 days
Authorization status:
OTC monograph not final
Authorization number:
69517-118-24

TENSION HEADACHE RELIEF- acetaminophen 500mg tablet, coated

Healthlife of USA

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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Tension Headache Relief

Drug Facts

Tension Headache Relief

Purpos e

Pain reliever, Pain reliever aid

Active Ingredients (in each caplet)

Acetaminophen 500mg

Caffeine 65mg

Us es

Temporarily relief minor aches and pains due to:

Headache

Muscular aches

Warnings

Liver warning: This product contains acetaminophen. severe liver damage may occur if you take:

more than 6 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

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 taking this product

because too much caffeine may cause nervousness, irritability, sleeplessness, and occasionally rapid

heartbeat.

Do not Use

with any other drug containing acetaminophen (prescription or nonprescription). Ask a doctor or

pharmacist before using with other drugs if you are not sure.

Ask a doctor before use

if you have liver disease

Ask a doctor or pharmacist

If you are taking the blood thinning drug warfarin.

Stop use and ask a doctor if

Any new symptoms appear

Symptoms do not get better or worsen

Painful area is red or swollen

pain gets worse or lasts for more than 10 days

fever gets worse or lasts for more than 3 days

If pregnant or breast-feeding

Ask a health professional before use.

Keep out of reach of children.

In case of overdosage, 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.

Directions

Do not exceed recommended dosage.

Adults and children 12 years and over: Take 2 tablets every 6 hours; do not take more than 6 tablets

in 24 hours

Children under 12 years: Ask a doctor

Other Information

Store at controlled room temperature 20°-25°C (68°-77°F)

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP

Inactive Ingredients

Colloidal silicon doixide

Croscarmellose sodium

D&C red # 27

FD&C blue # 1

FD&C yellow # 6

Magnesium stearate

Microcrystalline cellulose

Polyethylene glycol

Pregelatinized starch

Polyvinyl pyrolidone

Stearic acid

Talc

Titanium dioxide

Questions or comments?

Call toll free 1-844-832-1138 Monday through Friday 9AM - 5PM EST or www.healthlifeofusa.com

Tension Headache Relief

Acetaminophen 500mg

Caffeine 65mg

24 CapletsCompare to Excedrin® Tension Headache active ingredients Distributed by:

Healthlife of USA LLC

Rahway

NJ 07065

www.healthlifeofus a.com

TENSION HEADACHE RELIEF

acetaminophen 500mg tablet, coated

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 9 517-118

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

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

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

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

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

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

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

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

STEARIC ACID (UNII: 4ELV7Z6 5AP)

TALC (UNII: 7SEV7J4R1U)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

PO LYETHYLENE GLYCO LS (UNII: 3WJQ0 SDW1A)

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

Product Characteristics

Color

re d

S core

no sco re

S hap e

CAPSULE

S iz e

18 mm

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 9 517-118 -24

1 in 1 CARTON

0 5/31/20 17

1

24 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 5/31/20 17

Labeler -

Healthlife of USA (079656178)

Establishment

Healthlife of USA

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Healthlife o f USA

0 79 6 56 178

re pa c k(6 9 517-118 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Elysium Pharmaceuticals Limited

9 156 6 448 6

manufacture(6 9 517-118 ) , pack(6 9 517-118 )

Revised: 6/2017

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