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Diphenhydramine Citrate And Ibuprofen

Source: OpenFDA label data · Not medical advice · For personal tracking only

The most user-facing sections are shown first. FDA professional label details are kept below and collapsed because they can be technical, repetitive, or difficult to read out of context.

Safety Warning Highlights

9

Important warning themes extracted from the FDA label. Review the full label warnings below for source wording.

Allergy

Allergic ReactionAllergy AlertBlistersFacial SwellingHivesRashTrouble BreathingWheezing

Warnings Allergy alert 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.

Do not use Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer unless you have time for a full night's sleep in children under 12 years of age right before or after heart surgery with any other product containing diphenhydramine, even one used on skin if you have sleeplessness without pain Ask a doctor before use if Ask a doctor before use if stomach bleeding warning applies to you you have problems or serious side effects from taking pain relievers or fever reducers you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke you are taking a diuretic you have a breathing problem such as emphysema or chronic bronchitis you have glaucoma you have trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers, or any other sleep-aid under a doctor's care for any continuing medical illness taking any other antihistamines taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin taking any other drug When using this product drowsiness will occur avoid alcoholic drinks do not drive a motor vehicle or operate machinery take with food or milk if stomach upset occurs Stop use and ask a doctor if 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 you have symptoms of heart problems or stroke: chest pain trouble breathing weakness in one part or side of body slurred speech leg swelling pain gets worse or lasts more than 10 days sleeplessness persists continuously for more than 2 weeks.

Reported Side Effects

27

Serious — Get Medical Help

These may signal more serious reactions and may require prompt medical attention.

Other Reported Reactions

Also mentioned in the drug label or warning text.

Allergic Reaction

An immune reaction that may cause rash, swelling, hives, itching, or breathing problems.

FDA label warnings

1

Show full FDA warning text

Source label wording. This may be long, technical, or formatted for the original package label.

Warnings Allergy alert 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: 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 Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed. Do not use Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer unless you have time for a full night's sleep in children under 12 years of age right before or after heart surgery with any other product containing diphenhydramine, even one used on skin if you have sleeplessness without pain Ask a doctor before use if Ask a doctor before use if stomach bleeding warning applies to you you have problems or serious side effects from taking pain relievers or fever reducers you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke you are taking a diuretic you have a breathing problem such as emphysema or chronic bronchitis you have glaucoma you have trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers, or any other sleep-aid under a doctor's care for any continuing medical illness taking any other antihistamines taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin taking any other drug When using this product drowsiness will occur avoid alcoholic drinks do not drive a motor vehicle or operate machinery take with food or milk if stomach upset occurs Stop use and ask a doctor if 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 you have symptoms of heart problems or stroke: chest pain trouble breathing weakness in one part or side of body slurred speech leg swelling pain gets worse or lasts more than 10 days sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness. redness or swelling is present in the painful area any new symptoms appear If pregnant or breast-feeding, If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in 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. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Professional label: Usage and Indications

1

Show FDA label use text

Technical label wording. It may be incomplete, repetitive, or written for clinicians.

This is original FDA label wording organized for display. It is not a plain-language summary.

  • Uses for relief of occasional sleeplessness when associated with minor aches and pains helps you fall asleep and stay asleep

Professional label: Dosage Details

2

Show FDA label dosage text

Not dosing guidance. Follow your clinician, pharmacist, or product label.

This is original FDA label wording organized for display. It is not a personalized dosing recommendation.

  • Directions do not take more than directed
  • Adults and children 12 years and over: take 2 caplets at bedtime do not take more than 2 caplets in 24 hours