FDA Label for Gericare Liquid Pain Relief

View Indications, Usage & Precautions

Gericare Liquid Pain Relief Product Label

The following document was submitted to the FDA by the labeler of this product Geri-care Pharmaceuticals, Corp. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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


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