Pain Reliever
FDA Label NDC 67060-113

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Advanced First Aid, Inc. for the product Pain Reliever (NDC 67060-113). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Active Ingredient

ACTIVE INGREDIENT IN EACH TABLET- ACETAMINOPHEN 110 MG, ASPIRIN 162 MG, CAFFEINE 32.4 MG, SALICYLAMIDE 152 MG

Otc - Purpose

PAIN RELIEVER/FEVER REDUCER 

Indications & Usage

Uses:

temporarily relieves minor aches and pains associated with:

• headaches • colds • toothache • minor arthritis pain • muscular aches • menstrual cramps • backache

Warnings

Warnings:

Reye's syndrome:

Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behaviour with nausea and vomiting occur, consult a doctor, because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

Alergy 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.

Allergy Alert: Aspirin may cause a severe allergic reaction, which may include: • hives • facial swelling • asthma (wheezing) • shock

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

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 with 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

Caffeine Warning:

The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart beat.

Do not use:

• with any other product containing acetaminophen (prescription or nonprescription). This will provide more than the recommended dose (overdose) of acetaminophen and could cause serious health concerns.

• with any other pain reliever/fever reducer

• if you are allergic to aspirin

• if you have ever had an allergic reaction to any other pain reliever/fever reducer

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

Ask doctor before using if you have:

• stomach problems (such as heartburn, upset stomach or stomach pain)

• stomach bleeding warning applies to you

• gastric ulcers • bleeding problems

• you have asthma, high blood pressure, heart disease, liver disease, or kidney disease

• you are taking a diuretic

Ask a doctor or pharmacist before use if you are taking a prescription drug for:

•anticoagulation (thinning of blood) • diabetes • gout • arthritis

• und a doctor's care for any serious condition

• taking any other drug

When using this product do not exceed recommended dose.

Stop use and ask a doctor if:

• ringing in the ears or loss of hearing occurs

• pain or fever persists or gets worse

• new symptoms occur

• redness or swelling is present

• you feel faint, vomit blood or have bloody or black stools, have stomach pain that does not get better. These are signs of stomach bleeding.

• an allergic reaction occurs.

Seek medical help right away.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding baby, ask a health professional before use. IT IS ESPECIALLY IMPORTANT NOT TO USE ASPIRIN

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.

Otc - 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.

Dosage & Administration

Adults and children 12 years of age and older:Take 2 tablets every 4 hours as

 needed, with a full glass of water. Do not exceed 8 tablets in any 24 hour period.

Children under 12 years: ask a doctor.

Inactive Ingredient

FD&C yellow #6, magnesium stearate, microcrystalline cellulose, povidone, starch and stearic acid

Package Label.Principal Display Panel

Pain Reliever 250ct Box (Adv1staid Pain Reliever 1134 250ct)

Pain Reliever 250ct Box (Adv1staid Pain Reliever 1134 250ct)

Pain Reliever 250ct Box (Adv1staid Pain Reliever 1134 250ct)

Pain Reliever 250ct Box (Adv1staid Pain Reliever 1134 250ct)

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