Gericare-liquidpainrel 160

Gericare-liquidpainrel 160
SPL v8
SPL
SPL Set ID 85a074da-14b7-4db5-9d47-8ad19f520721
Route
ORAL
Published
Effective Date 2021-03-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (160 mg)
Inactive Ingredients
Anhydrous Citric Acid Fd&c Red No. 40 Methylparaben Polyethylene Glycol, Unspecified Propylene Glycol Propylparaben Water Sodium Citrate Sucralose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-05-01

Description

per 5 mL teaspoonful Acetaminophen - 160 mg


Medication Information

Warnings and Precautions

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 havea liver disease.

Ask a doctor before use if you aretaking 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.

Indications and 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
Dosage and 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)

Description

per 5 mL teaspoonful Acetaminophen - 160 mg

Section 50565-1

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.

Section 51727-6

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

Section 51945-4

Section 53413-1

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

Section 53414-9

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

Section 55105-1

Purpose

Pain Reliever

Fever Reducer

Section 55106-9

per 5 mL teaspoonful

Acetaminophen - 160 mg


Structured Label Content

Indications and Usage (34067-9)

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
Dosage and Administration (34068-7)

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)

Warnings and Precautions (34071-1)

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 havea liver disease.

Ask a doctor before use if you aretaking 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.

Section 50565-1 (50565-1)

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.

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

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

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Pain Reliever

Fever Reducer

Section 55106-9 (55106-9)

per 5 mL teaspoonful

Acetaminophen - 160 mg


Advanced Ingredient Data


Raw Label Data

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