ACETAMINOPHEN 160 mg / 5 ml Elixir

Acetaminophen is a pain reliever and a fever reducer.
Acetaminophen is used to treat mild to moderate and pain, to treat moderate to severe pain in conjunction with opiates, or to reduce fever. Common conditions that acetaminophen treats include headache, muscle aches, arthritis, backache, toothaches, colds, and fevers.

NDC: 71399-0160-04 for 118 ml
NDC: 71399-0160-08 for 236 ml
NDC: 71399-0160-06 for 473 ml

Children’s Pain Relief
Bubble Gum Flavor
Pain Reliever and Fever Reducer

Active ingredient (in each 5 mL = 1 teaspoonful)
Acetaminophen 160 mg

PURPOSE:
Pain Reliever/Fever Reducer

USES:
To reduce fever and for the temporary relief of 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:
Liver warning
This product contains acetaminophen. Severe liver damage may occur if

adult takes more than 6 doses in 24 hours, which is the maximum daily amount

child takes more 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.

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 (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if your child is allergic to acetaminophen or any of the inactive ingredients in this product

Ask a doctor before use if your child has

liver disease
is on a sodium-restricted diet.

Ask a doctor or pharmacist before us e if your child is taking the blood thinning drug warfarin

When using this product: Do not exceed recommended dose

Stop use and ask a doctor if:

  • Pain gets worse or lasts more than 5 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 right away. Quick medical
attention is critical for adults/children even if you do not notice any signs or symptoms.

DIRECTIONS:

  • shake well before using
  • find the right dose on chart below, if possible, use weight to dose; otherwise use age
  • dosage may be repeated every 4 hours, or as directed by your doctor
  • do not use more than 5 doses in 24 hours
  • do not use more than 5 days unless directed by a doctor.
  • find right dose on chart below, If possible, use weight to dose; otherwise, use age.

Weight (lbs.) Age (years) dosage-teaspoonful (tsp.)
under 24 under 2 consult Physician
24 to 35 2 to 3 1 tsp. (5 mL)
36 to 47 4 to 5 1 1/2 tsp. (7.5 mL)
48 to 59 6 to 8 2 tsp. (10 mL)
60 to 71 9 to 10 2 1/2 tsp. (12.5 mL)
72 to 95 11 3 tsp. (15 mL)
Other information
Store at room temperature 15°-30° C (59°-86°F)

Protect from Freezing.
Protect from Light.

TAMPER EVIDENT: DO NOT USE IF BREAKAWAY BAND ON CAP IS BROKEN OR MISSING.

INACTIVE INGREDIENTS:
Bubble Gum Flavor, Citric Acid, FD C RED #40, Glycerin, Polyethylene Glycol 400, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol Solution 70% & Sodium Benzoate.

Questions or Comments?
Call (877) 225-6999 Monday – Friday 9AM-5PM EST

Manufactured for
Akron Pharma, Inc.,
Fairfeld, NJ – 07004
Rev 09-19
Manufactured In USA

* This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the
registered trademark Tylenol Elixir

To report an adverse event, side effect, or product quality issue, please call 877-225-6999