Temp X

Temp X
SPL v5
SPL
SPL Set ID fd2edc32-0351-c991-e053-6294a90ab4ce
Route
ORAL
Published
Effective Date 2023-06-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (160 mg)
Inactive Ingredients
Fd&c Red No. 40 Glycerin High Fructose Corn Syrup Polysorbate 20 Propylene Glycol Water Sodium Benzoate Sucralose Sorbitol Xanthan Gum Carboxymethylcellulose Sodium, Unspecified Acesulfame Potassium Microcrystalline Cellulose Anhydrous Citric Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-06-02
Description

Acetaminophen 160 mg............. Pain reliever/fever reducer

Purpose

Acetaminophen 160 mg............. Pain reliever/fever reducer

Medication Information

Purpose

Acetaminophen 160 mg............. Pain reliever/fever reducer

Description

Acetaminophen 160 mg............. Pain reliever/fever reducer

Uses

temporarily:

  • reduces fever
  • relieves minor aches and pains due to:
  • sore throat
  • the common cold
  • flu
  • headache
  • toothache
Section 34088-5

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 as well as for children even if you do not notice any signs or symptoms.

Section 42229-5

When using this product do not exceed recommened dose (see overdose warning)

Section 50565-1

Keep out of reach of children.

Section 50566-9

Stop use and ask a doctor if

  • new sympthoms occur
  • redness or swelling is present
  • pain gets worse or lasts more than 5 days
  • fever gets worse or lasts more than 3 days

These could be signs of a serious condition

Section 50568-5

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

Section 50569-3

Ask a doctor before use if your child has liver disease.

Section 55105-1

Pain Reliever & Fever Reducer

Warnings

Liver warning: This product contains acetaminophen.



Severe liver damage may occur if your child takes takes

  • more than 5 doses in 24 hours. which is the maximum daily amount.
  • with other drugs containing acetaminophen.



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.

Directions
  • this product does not contain directions or complete warnings for adult use. Shake well before using
  • mL= millilitar
  • find right dose on chart below, if possible, use weight to dose; otherwise, use age
  • repeat dose every 4 hours while symptoms last
  • only use enclosed measuring syringe
  • do not give more than 5 times in 24 hours
  • do not give more than 5 days unless directed by a doctor

Weight (lb,) Age (yrs.) Dose (mL)*
Under 24 Under 2 Ask a doctor

24-35

2-3

 5 mL
36-47 4-5 7.5 mL
48-59 6-8 10 mL
60-71 9-10 12.5 mL
72-95 11 15 mL

*always check with your doctor before administering medicine to your infant/child

Do Not Use
  • with any other drug containing acetaminophen (prescnption 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.
Other Information
  • Each teaspoon (5 mL) contains: sodium 3 mg
  • Store between 15°-30°C (59°-86°F)
  • Protect from freezing. Protect from light

Inactive Ingredients

acesulfame potassium, citric acid, FD&C red no. 40, flavor, glycerine, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, polysorbate, propylene glycol, prosweet N&AK, purified water, sodium benzoate, sucralose, sorbitol, xanthan gum.

Questions Or Comments?

Call toll free 619-600-5632



Monday through Fnday 9AM - 5PM EST

Principal Display Panel

NDC 69729-047-04 Temp X

Active Ingredient(in Each 5 Ml) Purpose

Acetaminophen 160 mg............. Pain reliever/fever reducer

Structured Label Content

Uses

temporarily:

  • reduces fever
  • relieves minor aches and pains due to:
  • sore throat
  • the common cold
  • flu
  • headache
  • toothache
Section 34088-5 (34088-5)

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 as well as for children even if you do not notice any signs or symptoms.

Section 42229-5 (42229-5)

When using this product do not exceed recommened dose (see overdose warning)

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • new sympthoms occur
  • redness or swelling is present
  • pain gets worse or lasts more than 5 days
  • fever gets worse or lasts more than 3 days

These could be signs of a serious condition

Section 50568-5 (50568-5)

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

Section 50569-3 (50569-3)

Ask a doctor before use if your child has liver disease.

Section 55105-1 (55105-1)

Pain Reliever & Fever Reducer

Warnings

Liver warning: This product contains acetaminophen.



Severe liver damage may occur if your child takes takes

  • more than 5 doses in 24 hours. which is the maximum daily amount.
  • with other drugs containing acetaminophen.



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.

Directions
  • this product does not contain directions or complete warnings for adult use. Shake well before using
  • mL= millilitar
  • find right dose on chart below, if possible, use weight to dose; otherwise, use age
  • repeat dose every 4 hours while symptoms last
  • only use enclosed measuring syringe
  • do not give more than 5 times in 24 hours
  • do not give more than 5 days unless directed by a doctor

Weight (lb,) Age (yrs.) Dose (mL)*
Under 24 Under 2 Ask a doctor

24-35

2-3

 5 mL
36-47 4-5 7.5 mL
48-59 6-8 10 mL
60-71 9-10 12.5 mL
72-95 11 15 mL

*always check with your doctor before administering medicine to your infant/child

Do Not Use (Do not use)
  • with any other drug containing acetaminophen (prescnption 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.
Other Information (Other information)
  • Each teaspoon (5 mL) contains: sodium 3 mg
  • Store between 15°-30°C (59°-86°F)
  • Protect from freezing. Protect from light

Inactive Ingredients (Inactive ingredients)

acesulfame potassium, citric acid, FD&C red no. 40, flavor, glycerine, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, polysorbate, propylene glycol, prosweet N&AK, purified water, sodium benzoate, sucralose, sorbitol, xanthan gum.

Questions Or Comments? (Questions or comments?)

Call toll free 619-600-5632



Monday through Fnday 9AM - 5PM EST

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 69729-047-04 Temp X

Active Ingredient(in Each 5 Ml) Purpose (Active Ingredient(in each 5 mL) Purpose)

Acetaminophen 160 mg............. Pain reliever/fever reducer

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:26.780916 · Updated: 2026-03-14T23:05:11.503942