HANDY SOLUTIONS HEADACHE PAIN RELIEF- acetaminophen, aspirin, caffeine tablet, film coated

Handy Solutions Headache Pain Relief by

Drug Labeling and Warnings

Handy Solutions Headache Pain Relief by is a Otc medication manufactured, distributed, or labeled by Navajo Manufacturing Company Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients (in each tablet)

Acetaminophen 250 mg

Aspirin (NSAID*) 250 mg

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

Purposes

Pain Reliever/Fever Reducer

Pain Reliever Aid

Uses

For the temporary relief of minor aches and pains associated with
headache muscular aches minor arthritis pain back pain  common cold toothache menstrual cramps
Temporarily reduces fever.

Warnings

Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early of Reye’s syndrome, a rare but serious illness.

Allergy alert: Aspirin (NSAID) may cause a severe allergic reaction which may include:
hives skin reddening facial swelling rash asthma (wheezing)  shock blisters
If an allergic reaction occurs, stop use and seek medical help right away.

Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take:
more than 4,000 mg of acetaminophen in 24 hours
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
are age 60 or older
have had stomach ulcers or bleeding problems
take a blood thinning (anticoagulant) or steroid drug
take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
have 3 or more alcoholic drinks every day while using this product
take more or for a longer time than directed

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 heart beat.

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.
for pain for more than 10 days unless directed by a doctor
for more than 3 days for fever unless directed by a doctor
if you ever have had an allergic reaction to any other pain relievers/ fever reducers
right before or after heart surgery
if you are taking prescription drugs for gout, diabetes, or arthritis

Ask a doctor before use if

stomach bleeding warning applies to you
you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
you are taking a diuretic
you have a history of stomach problems such as heartburn
you have asthma

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin  under a doctor’s care for any serious condition taking any other drug

When using this product

take with food or milk if stomach upset occurs

Stop use and ask a doctor if

you experience any of the following signs of stomach bleeding:
feel faint vomit blood have bloody or black stools
have stomach pain that does not get better
symptoms do not improve pain gets worse or lasts more than 10 days
fever gets worse or lasts more than 3 days
ringing in the ears or loss of hearing occurs
redness or swelling is present in the painful area any new symptoms appear

If pregnant or breast-feeding,

ask a health care professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children.

In case of 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.

Directions

do not use more than directed
Adults and children (12 years and older): Take 2 tablets with water every 6 hours as needed. Do not take more than 8 tablets in 24 hours.
Children under 12 years: Do not give to children under 12 years of age.

Other Information

read all product information before using
store at room temperature 59°-86°F (15°-30°C)
avoid excessive heat and humidity tamper evident sealed packets
do not use any opened or torn packets

Inactive Ingredients

hypromellose, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, starch, stearic acid, titanium dioxide

Questions or comments?

call 1-800-525-5097

Package Labeling:

INGREDIENTS AND APPEARANCE

HANDY SOLUTIONS HEADACHE PAIN RELIEF 
acetaminophen, aspirin, caffeine tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67751-175(NDC:47682-228)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	250 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	250 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	65 mg

Inactive Ingredients
Ingredient Name	Strength
HYPROMELLOSES (UNII: 3NXW29V3WO)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white (white)	Score	no score
Shape	ROUND (ROUND)	Size	11mm
Flavor		Imprint Code	FR;9
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67751-175-01	1 in 1 CARTON	10/21/2016
1		1 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	10/21/2016

Labeler - Navajo Manufacturing Company Inc. (091917799)

Establishment
Name	Address	ID/FEI	Business Operations
Navajo Manufacturing Company Inc.		136941411	relabel(67751-175)