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Ibuprofen And Diphenhydramine Citrate

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

5

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

Allergy

Allergic ReactionAllergy AlertBlistersFacial SwellingHivesRashWheezing

Warnings 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.

Reported Side Effects

11

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: 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 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.

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 capsules at bedtime do not take more than 2 capsules in 24 hours Other information read all warnings and directions before use. Keep carton. store at 20° to 25°C 68° to 77°F) avoid excessive heat above 40°C 104°F)