Gericare Liquid Pain Relief Liquid
FDA Label NDC 57896-160

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Geri-care Pharmaceuticals, Corp for the product Gericare Liquid Pain Relief (NDC 57896-160). 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.

Label Section Quick Index

Otc - Active Ingredient

per 5 mL teaspoonful

Acetaminophen - 160 mg

Otc - Purpose

Purpose

Pain Reliever

Fever Reducer

Indications & Usage

Uses

  • temporarily relieves minor aches and pains due to 
  • headache 
  • muscular aches 
  • backache 
  • minor pain of arthritis 
  • the common cold 
  • toothache 
  • premenstrual and menstrual cramps 
  • temporarily reduces fever Warnings

Warnings

Warnings

Liver warning: This product contains acetaminophen. Severe liver damagemayoccurif: •adulttakesmorethan6dosesin24 hours,whichisthemaximumdailyamount •childtakesmore than 5 doses in 24 hours, which is the maximum daily amount • taken with other drugs containing acetaminophen • adult has 3 or more alcoholic drinks everyday while using this product

Allergy 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.

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.

Ask a doctor before use if you have a liver disease.

Ask a doctor before use if you are taking the blood thinning drug warfarin.

Stop use and ask a doctor if • pain gets worse or lasts more than 10daysinadults •paingetsworseorlastsmorethan5daysin children under 12 years • fever gets worse or lasts more than 3 days •newsymptomsoccur •rednessorswellingispresent. These could be signs of a serious condition.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - 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. Quick medical attention is critical for adults/children even if you do not notice any signs or symptoms.

Dosage & Administration

Directions

  • do not take more than directed
  • find dose in chart below
  • if possible, use weight to dose, otherwise use age
  • doasge may be repeated every 4 hours, or as directed by a doctor
  • do not give more than 5 doses in 24 hours
    •  Weight (lbs) Under 24 24 - 35 36 - 47 48 - 59 60 - 71 72 - 95 Over 95
     Age (years) Under 2 2 to 3 4 to 5 6 to 8 9 to 10 11 12 to adult
     Dosage Teaspoonful (tsp) consult physician 1 tsp (5 mL) 1 1/2 tsp (7.5 mL) 2 tsp (10 mL) 2 1/2 tsp (12.5 mL) 3 tsp (15 mL) 4 tsp (20 mL)

Inactive Ingredient

Inactive ingredients: artificial and natural cherry flavor, citric acid, FD&C Red #40, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate, sucralose

Otc - Questions

DIST. BY: Geri-Care Pharmaceuticals Corp. 1650 63rd Street 3 Brooklyn, NY 11204

Package Label.Principal Display Panel

Geriaceta (Geriacetasm)

Geriaceta (Geriacetasm)

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