Equaline Ibuprofen

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Equaline Ibuprofen Recall

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Questions & Answers

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Side Effects & Adverse Reactions

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

•: hives
•: facial swelling
•: asthma (wheezing)
•: shock
•: skin reddening
•: rash
•: 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 your child:

•: has had stomach ulcers or bleeding problems
•: takes a blood thinning (anticoagulant) or steroid drug
•: takes other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
•: takes more or for a longer time than directed

Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by doctor.

Do not use

•: if the child has 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 your child
•: child has a history of stomach problems, such as heartburn
•: child has problems or serious side effects from taking pain relievers or fever reducers
•: child has not been drinking fluids
•: child has lost a lot of fluid due to vomiting or diarrhea
•: child has high blood pressure, heart disease, liver cirrhosis, or kidney disease
•: child has asthma
•: child is taking a diuretic

Ask a doctor or pharmacist before use if the child is

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

When using this product

•: give with food or milk if stomach upset occurs
•: the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

Stop use and ask a doctor if

•: child experiences any of the following signs of stomach bleeding:
•: feels faint
•: vomits blood
•: has bloody or black stools
•: has stomach pain that does not get better
•: the child does not get any relief within first day (24 hours) of treatment
•: fever or pain gets worse or lasts more than 3 days
•: redness or swelling is present in the painful area
•: any new symptoms appear

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Do not use

•: if the child has 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 your child
•: child has a history of stomach problems, such as heartburn
•: child has problems or serious side effects from taking pain relievers or fever reducers
•: child has not been drinking fluids
•: child has lost a lot of fluid due to vomiting or diarrhea
•: child has high blood pressure, heart disease, liver cirrhosis, or kidney disease
•: child has asthma
•: child is taking a diuretic

Ask a doctor or pharmacist before use if the child is

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

Stop use and ask a doctor if

•: child experiences any of the following signs of stomach bleeding:
•: feels faint
•: vomits blood
•: has bloody or black stools
•: has stomach pain that does not get better
•: the child does not get any relief within first day (24 hours) of treatment
•: fever or pain gets worse or lasts more than 3 days
•: redness or swelling is present in the painful area
•: any new symptoms appear

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Legal Issues

There is currently no legal information available for this drug.

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FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

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FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

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Uses

temporarily:

•: reduces fever
•: relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches

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History

There is currently no drug history available for this drug.

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Other Information

There are no additional details available for this product.

Sources

Equaline Ibuprofen Manufacturers

Supervalu Inc

Equaline Ibuprofen | Supervalu Inc

• this product does not contain directions or complete warnings for adult use • do not give more than directed • shake well before using • find right dose on chart below. If possible, use weight to dose; otherwise use age. • measure with the dosing device provided. Do not use with any other device. • dispense liquid slowly into the child’s mouth, toward the inner cheek • if needed, repeat dose every 6-8 hours • do not use more than 4 times a day
Dosing Chart

Weight (lbs)

Age (mos)

Dose (mL)

under 6 mos

ask a doctor

12-17 lbs

6-11 mos

1.25 mL

18-23 lbs

12-23 mos

1.875 mL

No Recall
Supervalu Inc

Equaline Ibuprofen | Supervalu Inc

do not take more than directed the smallest effective dose should be used adults and children 12 years and older take 1 caplet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 caplet, 2 caplets may be used do not exceed 6 caplets in 24 hours, unless directed by a doctor children under 12 years ask a doctor

No Recall
Supervalu Inc

Equaline Ibuprofen | Supervalu Inc

do not take more than directed the smallest effective dose should be used

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 ask a doctor

No Recall
Supervalu Inc

Equaline Ibuprofen | Perrigo New York Inc

• if you are under 18 years of age, ask a doctor before use • before using this product, read the enclosed User’s Guide for complete directions and other important information • begin using the gum on your quit day • if you smoke your first cigarette within 30 minutes of waking up, use Nicotine Polacrilex Gum, 4 mg • if you smoke your first cigarette more than 30 minutes after waking up, use Nicotine Polacrilex Gum, 2 mg according to the following 12 week schedule:
Weeks 1 to 6

Weeks 7 to 9

Weeks 10 to 12

1 piece every

1 to 2 hours

1 piece every

2 to 4 hours

1 piece every

4 to 8 hours
• nicotine gum is a medicine and must be used a certain way to get the best results • chew the gum slowly until it tingles. Then park it between your cheek and gum. When the tingle is gone, begin chewing again, until the tingle returns. • repeat this process until most of the tingle is gone (about 30 minutes) • do not eat or drink for 15 minutes before chewing the nicotine gum, or while chewing a piece • to improve your chances of quitting, use at least 9 pieces per day for the first 6 weeks • if you experience strong or frequent cravings, you may use a second piece within the hour. However, do not continuously use one piece after another since this may cause you hiccups, heartburn, nausea or other side effects. • do not use more than 24 pieces a day • it is important to complete treatment. If you feel you need to use the gum for a longer period to keep from smoking, talk to your health care provider.

No Recall
Supervalu Inc

Equaline Ibuprofen | Paramesh Banerji Life Sciences Llc

Adult or child: Take three pills daily. Leaving a gap of 30 minutes after any food or as advised by your physician.

No Recall
Supervalu Inc

Equaline Ibuprofen | Amerisource Bergen

• adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period. • children under 6 years of age: ask a doctor
Shake well before use. Before using the first time, unlock pump, remove the protective cap from the tip and prime metered pump by depressing pump firmly several times. To spray, hold bottle with thumb at base and nozzle between first and second fingers. Without tilting head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and sniff deeply. Wipe nozzle clean after use. Lock pump to maintain child resistance.

No Recall
Supervalu Inc

Equaline Ibuprofen | Supervalu Inc

• do not take more than directed • the smallest effective dose should be used
adults and children 12 years and

older
• take 1 caplet every 4 to 6 hours while symptoms persist • if pain or fever does not respond to 1 caplet, 2 caplets may be used • do not exceed 6 caplets in 24 hours, unless directed by a doctor
children under 12 years
• ask a doctor

No Recall
Supervalu Inc

Equaline Ibuprofen | Supervalu Inc

• do not take more than directed • the smallest effective dose should be used
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
• ask a doctor

No Recall