TYLENOL description, usages, side effects, indications, overdosage, supplying and lots more!

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TYLENOL

McNeil Consumer Healthcare Div McNeil-PPC, Inc

TYLENOL SORETHROAT


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient (in each 15 mL = 1 tablespoon)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

TYLENOL Uses

  • temporarily relieves minor aches and pains due to:
    • the common cold
    • headache
    • sore throat
    • muscular aches
  • temporarily reduces fever

Warnings

Alcohol warning

If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers or fever reducers. Acetaminophen may cause liver damage.

Sore throat warning

if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly.

Do not use

  • with any other drug containing acetaminophen

Stop use and ask a doctor if

  • 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

These could be signs of a serious condition.

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

Keep out of reach of children.

Overdose warning

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

  • do not take more than directed (see overdose warning)
  • do not take for more than 10 days unless directed by a doctor
adults and children 12 years and over
  • take 2 tablespoons (tbsp) or 30 mL in dosing cup provided every 4 to 6 hours while symptoms last
  • do not take more than 8 tablespoons in 24 hours
children under 12 years do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

Other Information

  • each tablespoon contains: sodium 11 mg
  • do not use if plastic neck wrap or foil inner seal imprinted with "Safety Seal®" is broken or missing
  • store between 20-25°C (68-77°F)
  • see back label for lot number and expiration date

Inactive ingredients

citric acid, FD&C blue #1, flavors, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium carboxymethylcellulose, sorbitol, sucralose, sucrose

Questions or comments?

call 1-877-895-3665 (English) or 1-888-466-8746 (Spanish)

PRINCIPAL DISPLAY PANEL

NDC 50580-813-08

TYLENOL®
SORE
THROAT
Pain Reliever, Fever Reducer

CONTAINS 1 MEDICINE:

Sore Throat/Fever
Body Aches/Headache
Acetaminophen
500 mg per 15 mL

DAYTIME
Non-Drowsy

with INSTANT
Cool Burst™
SENSATION
8 FL OZ (240 mL)

TYLENOL

TYLENOL

Acetaminophen LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:50580-813
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 500 mg

Inactive Ingredients

Ingredient Name Strength
ANHYDROUS CITRIC ACID
FD&C BLUE NO. 1
polyethylene glycol
propylene glycol
water
SODIUM BENZOATE
CARBOXYMETHYLCELLULOSE SODIUM
sorbitol
Sucralose
SUCROSE

Product Characteristics

Color
BLUE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:50580-813-08 240 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2005-01-01


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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