First Aid Only Ibuprofen: Package Insert and Label Information

FIRST AID ONLY IBUPROFEN- ibuprofen tablet, coated
Acme United Corporation

Drug Facts

Active ingredient

Ibuprofen 200 mg (NSAID)

*nonsteroidal antinflamatory drug

Purpose

Pain reliever/fever reducer

Uses

Temporarily relieves minor aches and pains associated with

■ headache ■ toothache ■ backache ■ menstrual cramps

■ common cold ■ muscular aches ■ minor arthritis pain

Temporarily reduces fever

Warnings

Allergy alert:

Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

■ hives ■ skin reddening ■ asthma (wheezing) ■ facial swelling ■ rash ■ shock ■ blisters

If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning:

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

Do not use

■ if you have ever had an allergic reaction to any other pain reliever/fever reducer

■ right before or after heart surgery

Ask a doctor before use if

■ you have problems or serious side effects from taking pain relievers or fever reducers

■ stomach bleeding warning applies to you

■ you have a history of stomach problems such as heartburn

■ you have high blood pressure, heart disease, liver cirrhosis, or kidney disease

■ you have asthma

■ you are taking a diuretic

Ask a doctor or pharmacist before use if you are

■ taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin

■ 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

■ the risk of heart attack or stroke may increase if you use more than directed or longer than directed

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

■ pain gets worse or lasts for more than 10 days

■ fever gets worse or lasts for more than 3 days

■ redness or swelling is present in the painful area

■ any new or unexpected symptoms occur

If pregnant or breast feeding , ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless specifically directed to do so by a doctor because it may cause problems in he 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.

Directions

do not use more than directed

the smallest effective dose should be used

■ do not take longer than 10 days, unless directed by a doctor (see Warnings)

Adults and children: (12 years and older)

Take 1 tablet every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 tablet, 2 tablets may be used.
Do not exceed 6 tablets in 24 hours, unless directed by a doctor.

Children under 12 years:

Do not give to children under 12 years of age.

Other information

■ read all product information before using

■ store at 68-77°F (20-25°C)

■ avoid excessive heat 40°C (above 104°F)

■ tamper evident sealed packets

■ do not use any opened or torn packets

Inactive ingredients

carnauba wax*, corn starch, hypromellose*, iron oxide red, lactose*, magnesium stearate*, microcrystalline cellulose*, polydextrose*, polyethylene glycol, polyvinyl alcohol*, povidone K30*, silicon dioxide, sodium starch glycolate, stearic acid, talc*, titanium dioxide

*may contain

Questions? 1-800-835-2263

First Aid Only Ibuprofen Label

First Aid Only Ibuprofen Label

First Aid Only Ibuprofen Label
(click image for full-size original)
FIRST AID ONLY IBUPROFEN
ibuprofen tablet, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0924-0276(NDC:47682-700)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (IBUPROFEN) IBUPROFEN 200 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
STEARIC ACID
TITANIUM DIOXIDE
SILICON DIOXIDE
POVIDONE K30
FERRIC OXIDE RED
SODIUM STARCH GLYCOLATE TYPE A POTATO
POLYVINYL ALCOHOL, UNSPECIFIED
TALC
POLYETHYLENE GLYCOL, UNSPECIFIED
Product Characteristics
Color red (Reddish Brown) Score no score
Shape ROUND Size 10mm
Flavor Imprint Code G;2
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0924-0276-01 20 PACKET in 1 BOX, UNIT-DOSE contains a PACKET
1 2 TABLET, COATED in 1 PACKET This package is contained within the BOX, UNIT-DOSE (0924-0276-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079174 01/26/2017
Labeler — Acme United Corporation (001180207)
Registrant — Acme United Corporation (001180207)
Establishment
Name Address ID/FEI Operations
Acme United Corporation 045924339 relabel (0924-0276), repack (0924-0276)
Establishment
Name Address ID/FEI Operations
Acme United Corporation 080119599 relabel (0924-0276), repack (0924-0276)

Revised: 11/2019 Acme United Corporation

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