Tension Headache Relief: Package Insert and Label Information

TENSION HEADACHE RELIEF- acetaminophen and caffeine capsule
Allegiant Health

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.

Active ingredient (in each caplet)

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

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you ■ take more than 8 tablets in 24 hours, which is the maximum daily amount ■ take with other drugs containing acetaminophen ■ have 3 or more alcoholic drinks every day while using this product

Allergy alert: Aspirin may cause a severe allergic reaction which may include: ■ hives ■ facial swelling ■ asthma (wheezing) ■ shock
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 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 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 PoisonControlCenter 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.

Package/Label Principal Display Panel

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*Compare to the active ingredients in Excedrin® Tension Headache

See new warnings information

TENSION HEADACHE RELIEF
Acetaminophen and Caffeine
Aspirin Free
Pain Reliever/Pain Reliever Aid

Caplets

Tension Headache Relief 24ct. Caplets
(click image for full-size original)

Tension Headache Relief 24ct. Caplets

Tension Headache Relief 24ct. Caplets
(click image for full-size original)

Tension Headache Relief 24ct. Caplets

TENSION HEADACHE RELIEF
tension headache relief capsule
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:69168-029
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 500 mg
CAFFEINE (CAFFEINE) CAFFEINE 65 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
STARCH, CORN
CROSCARMELLOSE SODIUM
D&C RED NO. 27
FD&C RED NO. 40
FD&C YELLOW NO. 6
HYPROMELLOSES
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL, UNSPECIFIED
STEARIC ACID
TITANIUM DIOXIDE
Product Characteristics
Color RED Score no score
Shape CAPSULE Size 17mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69168-029-24 24 CAPSULE in 1 BOTTLE None
2 NDC:69168-029-98 200 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part343 11/26/2014
Labeler — Allegiant Health (079501930)

Revised: 11/2017 Allegiant Health

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