Tension headache relief capsule

Active ingredient

Acetaminophen 500 mg
Caffeine 65mg

Purpose

Pain reliever
Pain reliever aid

Uses

Temporary relief of minor aches and pains due to
headache
muscular aches

Warnings

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 doctor before use if you have

liver disease

Stop use and ask a doctor if

any new symptoms occur
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 accidental overdose, get medical help or contact a Poison Control Center immediately. Prompt 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 8 tablets in 24 hours

Children under 12 years:ask a doctor

Inactive ingredients

colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, D&C Red #27, FD&C Red #40, FD&C Yellow #6, hypromellose, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, stearic acid, titanium dioxide.

Ingredients and appearance - Product information

Tension headache relief capsule- Tension headache relief

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 62211-029
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Acetaminophen ( UNII: 362O9ITL9D)( Acetaminophen - UNII: 362O9ITL9D ) 500 ugin 1
Caffeine ( UNII: 3G6A5W338E)( Caffeine - UNII: 3G6A5W338E ) 65 mgin 1

Inactive Ingredients

Ingredient Name Code
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Starch, corn ( UNII: O8232NY3SJ)
Croscarmellose sodium ( UNII: M28OL1HH48)
Crospovidone ( UNII: 68401960MK)
D&c red no. 27 ( UNII: 2LRS185U6K)
Fd&c red no. 40 ( UNII: WZB9127XOA)
Fd&c yellow no. 6 ( UNII: H77VEI93A8)
Hypromelloses ( UNII: 3NXW29V3WO)
Cellulose, microcrystalline ( UNII: OP1R32D61U)
Polyethylene glycols ( UNII: 3WJQ0SDW1A)
Stearic acid ( UNII: 4ELV7Z65AP)
Titanium dioxide ( UNII: 15FIX9V2JP)

Product Characteristics

Color RED Size 17 mm
Shape CAPSULE Score 1

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph not final part343 USA

Labeler - A&Z Pharmaceutical, Inc.( 926820705)

Establishment

Name ID/FEI Business Operations
A&Z Pharmaceutical, Inc. 926820705 LABEL( 62211-029), MANUFACTURE( 62211-029), PACK( 62211-029), RELABEL( 62211-029), REPACK( 62211-029)

Package/label principal display panel