Medi-first Ibuprofen
FDA Label NDC 47682-708

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Unifirst First Aid Corporation for the product Medi-first Ibuprofen (NDC 47682-708). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding extra strength non-aspirin, extra strengh non-aspirin, antacid, cold relief, ibuprofen, diamode, outer carton pdp, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Extra Strength Non-aspirin

→ Extra Strengh Non-aspirin

→ Antacid

→ Cold Relief

→ Ibuprofen

→ Diamode

→ Outer Carton Pdp

Extra Strength Non-Aspirin

Active ingredient (in each tablet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

For the temporary relief of minor aches and pains associated with

headache
muscular aches
minor arthritis pain
common cold
toothache
menstrual cramps

For the reduction of fever.

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
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product

Allergy alert: 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.

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 more than 10 days for pain unless directed by a doctor
for more than 3 days for fever unless directed by a doctor

Ask a doctor before use if you have liver disease

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

Stop using and ask a doctor if

symptoms do not improve
new symptoms occur
pain or fever persists or gets worse
redness or swelling is present

If pregnant or breast-feeding, ask a health professional before use.

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.

Other information

store at room temperature 59° - 86°F (15° - 30°C)
tamper evident sealed packets
do not use any opened or torn packets

Inactive ingredients

corn starch, hypromellose, maltodextrin*, microcrystalline cellulose*, polyethylene glycol, povidone*, pregelatinized starch*, sodium starch glycolate*, stearic acid, titanium dioxide*.
* may contain

Questions? 1-800-634-7680

EXTRA STRENGTH

NON-ASPIRIN

2 Tablets

Mfd. for MEDIQUE PRODUCTS • Fort Myers, FL 33967

Extra Strengh Non-Aspirin

Directions

do not use more than directed

Adults and children:

(12 years and older)

Take 2 tablets with water every 4 to 6 hours as needed.

Do not take more than 8 tablets in 24 hours.

Children under 12 years:

Do not give this adult strength product to children under

12 years of age; this will provide more than the recommended

dose (overdose) and may cause liver damage.

Antacid

Active ingredient (in each tablet)

Calcium Carbonate 420 mg

Purpose

Antacid

Uses

For the relief of the following symptoms associated with

acid indigestion
sour stomach
heartburn
upset stomach

Warnings

Ask a doctor or health professional before use if you have

been taking a prescription drug. Antacids may interact with certain prescription drugs
kidney stones
a calcium-restricted diet

Stop using this product and ask a doctor if symptoms last more than 2 weeks

Do not exceed recommended dosage.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of the reach of children.

Directions

do not use more than directed
Adults and children (12 years and older): Chew 2 tablets every 2 or 3 hours as symptoms occur or as directed by a physician. Do not take more than 19 tablets in a 24 hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a physician.
Children under 12 years: Do not give to children under 12 years of age.

Other information

Phenylketonurics: contains phenylalanine 1.5 mg per tablet
each tablet contains 168 mg of elemental calcium
store at room temperature 59° - 86°F (15° - 30°C)
tamper-evident sealed packets
do not use any opened or torn packets

Inactive ingredients

aspartame*, croscarmellose sodium*, gum acacia*, magnesium stearate, maltodextrin, mineral oil*, mint flavor, sorbitol*, sucrose*.
* may contain

Questions or comments? call 1-800-634-7680

ANTACID

2 Tablets

Mfd for MEDIQUE PRODUCTS, Fort Myers, FL 33967

Antacid (Antacid)

Cold Relief

Active ingredient (in each tablet)

Acetaminophen 325 mg

Dextromethorphan Hydrobromide 15 mg

Guaifenesin 200 mg

Phenylephrine Hydrochloride 5 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Uses

Temporarily relieves these cold symptoms

cough
sore throat
minor aches and pains
headache
nasal congestion
helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Temporarily reduces fever.

Warnings

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

Allergy alert: 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.

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly.

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.
if you have ever had an allergic reaction to this product or any of its ingredients
if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

liver disease
heart disease
high blood pressure
thyroid disease
diabetes
trouble urinating due to an enlarged prostate gland
cough that occurs with too much phlegm (mucus)
persistent or chronic cough that lasts as occurs with smoking, asthma, chronic bronchitis or emphysema

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin

When using this product

do not use more than directed

Stop use and ask a doctor if

new symptoms occur
redness or swelling is present
pain or nasal congestion gets worse or lasts for more than 7 days
fever gets worse or lasts for more than 3 days
you get nervous, dizzy or sleepless
cough comes back or occurs with rash or headache that lasts.

These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

Directions

Adults and children:

(12 years and older)

Take 2 tablets with water every 6-8 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

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 maltodextrin, microcrystalline cellulose, povidone, sodium starch glycolate, starch, stearic acid

Questions?

1-800-634-7680

COLD RELIEF

2 Tablets

Mfd for MEDIQUE PRODUCTS, Fort Myers, FL 33967

Ibuprofen

Active ingredient (in each tablet)

Ibuprofen 200 mg (NSAID)*

*non-steroidal anti-inflammatory 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: 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
taking 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

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 are taking a diuretic
you have problems or serious side effects from taking pain relievers or fever reducers
you have asthma

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
taking any other drug
under a doctor’s care for any serious condition

When using this product

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

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 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.

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 for 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 104°F (above 40°C)
tamper evident sealed packets
do not use any opened or torn packet

Inactive ingredients

carnauba wax*, corn starch, hypromellose*, iron oxide red, lactose*, magnesium stearate*, microcrystalline cellulose*, polydextrose*, polyethylene glycol, polyvinyl alcohol*, povidone (K-30)*, silicon dioxide, sodium starch glycolate, stearic acid, talc*, titanium dioxide

* may contain

Questions or comments?1-800-634-7680

IBUPROFEN

2 Tablets

Mfd. for: MEDIQUE PRODUCTS • Fort Myers, FL 33967

Ibuprofen (Ibuprofen)

Diamode

Active ingredient (in each caplet)

Loperamide Hydrochloride 2 mg

Purpose

Antidiarrheal

Uses

Controls the symptoms of diarrhea, including Traveler's diarrhea

Warnings

Allergy alert: Do not use if you have ever had a rash or other allergic reaction to Loperamide HCl

Do not use if you have bloody or black stool

Ask a doctor before use if you have

a fever
mucus in stool
a history of liver disease

Ask a doctor or pharmacist before use if you are taking antibiotics

When using this product

tiredness, drowsiness or dizziness may occur
be careful when driving or operating machinery

Stop use and ask a doctor if

symptoms get worse
diarrhea lasts more than 2 days
upi get abdominal swelling or bulging. These may be signs of a serious condition.

If you are pregnant or breast-feeding, ask a health professional before use

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
drink plenty of clear fluids to help prevent dehydration caused by diarrhea

Adults and children:

(12 years and older)

Take 2 caplets after the first loose stool

followed by 1 caplet after each subsequent

loose stool but no more than 4 caplets in 24 hours.

Children under 12 years:

Do not give to children under 12 years of age.

Other information

store at room temperature 68° - 77°F (20° - 25°C)
tamper-evident sealed packets
do not use any opened or torn packet

Inactive ingredients anhydrous lactose, croscarmellose sodium, crospovidone, D&C Yellow #10, FD&C Blue #1, hydrogenated vegetable oil, magnesium stearate, powdered cellulose, pregelatinized starch

Questions or comments? 1-800-634-7680

Medique

Diamode

1 Caplet

Mfd. for MEDIQUE PRODUCTS, Fort Myers, FL 33967