FDA label 4a4e2759-49f0-20db-e054-00144ff8d46c

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

SPL set ID
4a4e2759-49ef-20db-e054-00144ff8d46c
SPL ID
4a4e2759-49f0-20db-e054-00144ff8d46c
Version
1
Effective date
2017-03-09
Source export date
2026-08-08
Source partition
9
Source file
https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-08/ff6f8a7e8311a0dd3c947cd18ca343b8c43f8b6003d238bee8402e80a049f204/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
b39f3b00ad50d2e1b32aaf429248c6081e8799b35bce715b4fccb8cfa1ac4546
Import run
20260810T161303Z
Imported at
2026-08-10 17:24:23

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 2 · 6 matching rows.

warnings

Warnings - After Bite Wipes For External Use Only

warnings

Warnings and Precautions - Ibuprofen Allergy alert: ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: shock, facial swelling, asthma (wheezing), rash, skin reddening, blisters, and hives, if an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: this product contains a nonsteroidal anti-inflammatory drug (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 thinner (anticoagulant) or steroid drug, take other drugs containing 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, fight before or after heart surgery. Ask a doctor before use if stomach bleeding warning applies to you, you have had a history of stomach problems such as heartburn, you have a high blood pressure, heart disease, liver cirrhosis, or kidney disease, you are taking a diuretic. Ask a doctor before use if you are taking any other drug containing NSAID (prescription or nonprescription), taking aspirin for heart attack or stroke, because Ibuprofen may decrease this benefit of aspirin, taking any other drug. When using this product 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, feeling faint, vomit blood, have bloody or black stools, have stomach pain that does not get better, pain gets worse or lasts more than 10 days, fever gets worse or lasts more than 3 days, redness or swelling is present in the painful area, any new symptoms appear. 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 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. In case of overdose, get medical help or contact a poison control center right away. Store at controlled room temperature, avoid excessive heat 40 degrees Celsius (104 degrees Fahrenheit); temper evident sealed packets, do not use any opened or torn packets. 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. 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, 3 tablets may be use. Do not exceed 6 tablets in 24 hours, unless directed by a doctor. Children under 12 years: do not give children under 12 years of age.

warnings

Warnings and Precautions - APAP Liver Warning: This product contains acetaminophen. Severe liver damage may occur if: adult takes more than 12 tablets in 24 hours, which is the maximum daily amount, child takes more than 5 doses in 24 hours, taken with other drugs containing acetaminophen, adult has 3 or more alcoholic drinks ever day while using this product. 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 the user has liver disease. Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin. Stop use and ask a doctor if: symptoms do not improve, pain gets worse or lasts more than 10 days, fever gets worse or lasts more than 3 days, new symptoms occur, redness or swelling is present, a rare sensitivity reaction occurs. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of accidental overdose, contact a doctor or Poison Control Center immediately. Prompt medical attention is critical for adults as well for children even if you do not notice any signs or symptoms. Do not exceed recommended dosage. Store at 59-86 degrees F (15-30 degrees C), tamper evident sealed packets, do not use any open or torn packets.

warnings

Warnings and Precautions - Diphenhydramine Do not use to make a child sleepy or with any other product containing diphenhydramine, even one that is used on skin. Ask a doctor before use if you have: a breathing problem such as emphysema or chronic bronchitis, difficulty in urination due to enlargement of the prostate gland, or glaucoma. Ask a doctor pharmacist before you use if you are taking sedatives or tranquilizers. When using this product: marked drowsiness may occur, avoid alcoholic beverages, alcohol, sedatives and tranquilizers may increase the drowsiness effect, use caution when driving a motor vehicle or operating machinery, excitability may occur, especially in children. If pregnant or breast feeding, ask a health professional before use. Keep out of reach of Children. In case of overdose, contact a physician or poison control center immediately. Each caplet may contain calcium 25mg. Store at room temperature 59-86 degrees F (15-30 C), protect from light and use by expiration date on packet. Tamper-evident sealed packets, do not use any opened or torn packets.