Temperal-ito - DailyMed Details

Temperal-ito

SPL v6

SPL

SPL Set ID fd2d85a0-4bc6-3ed0-e053-6294a90a8494

Route

ORAL

Published

Effective Date 2023-06-30

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (160 mg)

Inactive Ingredients

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

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2023-06-02

Description

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

Purpose

Pain Reliever & Fever Reducer

Medication Information

Purpose

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 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 50567-7

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

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 51945-4

NDC 69729-006-02

Section 55105-1

Pain Reliever & Fever Reducer

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.

Warnings 60 Ml

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.

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

skin reddening
blister
rash

if a skin reaction occurs, stop use and seek medical help right away.

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.

Warnings 118 Ml

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.

Other Information

store between 20°-25°C (68°-77°F)
protect from freezing
protect from light

Other Information

Each teaspoon (5 mL) contains: sodium 3 mg
Store between 15°-30°C (59°-86°F)
Protect from freezing. Protect from light

Directions 60 Ml

this product does not contain directions or complete warnings for adult use
do not give more than directed (see overdose warning)
shake well before using
mL= milliliter
find right dose on chart below, if posible, use weight to dose; otherwise, use age
only use enclosed measuring syringe
repeat dose ebery 4 hours while symptoms last
do not give more than 5 times in 24 hours

Weight (lb)	Age (yr)	Dose (mL) *
under 24	under 2 years	ask a doctor
24-35	2-3 years	5 mL

*or as directed by doctor

Directions 118 Ml

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 (Ib)	Age (yr)	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

Inactive Ingredients

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

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 69729-006-04 Temperal-ito

Active Ingredient(in Each 5 Ml) Purpose 60 Ml

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

Active Ingredient(in Each 5 Ml) Purpose 118 Ml

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)

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 50567-7 (50567-7)

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

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 51945-4 (51945-4)

NDC 69729-006-02

Section 55105-1 (55105-1)

Pain Reliever & Fever Reducer

Purpose

Pain Reliever & Fever Reducer

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.

Warnings 60 Ml (Warnings - 60 mL)

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.

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

skin reddening
blister
rash

if a skin reaction occurs, stop use and seek medical help right away.

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.

Warnings 118 Ml (Warnings -118 mL)

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.

Other Information

store between 20°-25°C (68°-77°F)
protect from freezing
protect from light

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

Directions 60 Ml (Directions - 60 ml)

this product does not contain directions or complete warnings for adult use
do not give more than directed (see overdose warning)
shake well before using
mL= milliliter
find right dose on chart below, if posible, use weight to dose; otherwise, use age
only use enclosed measuring syringe
repeat dose ebery 4 hours while symptoms last
do not give more than 5 times in 24 hours

Weight (lb)	Age (yr)	Dose (mL) *
under 24	under 2 years	ask a doctor
24-35	2-3 years	5 mL

*or as directed by doctor

Directions 118 Ml (Directions - 118 mL)

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 (Ib)	Age (yr)	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

Inactive Ingredients

Inactive Ingredients (Inactive ingredients)

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 69729-006-04 Temperal-ito

Active Ingredient(in Each 5 Ml) Purpose 60 Ml (Active Ingredient(In each 5 mL) Purpose - 60 mL)

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

Active Ingredient(in Each 5 Ml) Purpose 118 Ml (Active Ingredient(in each 5 mL) Purpose - 118 mL)

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

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "temporarily: reduces fever relieves minor aches and pains due to: sore throat the common cold flu headache toothache", "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.", "50565-1": "Keep out of reach of children.", "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", "50567-7": "When using this product do not exceed recommened dose (see overdose warning)", "50568-5": "Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin.", "50569-3": "Ask a doctor before use if your child has liver disease.", "51945-4": "NDC 69729-006-02", "55105-1": "Pain Reliever & Fever Reducer", "Purpose": "Pain Reliever & Fever Reducer", "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.", "Warnings - 60 mL": "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. Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blister rash if a skin reaction occurs, stop use and seek medical help right away. 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.", "Warnings -118 mL": "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.", "Other Information": "store between 20°-25°C (68°-77°F) protect from freezing protect from light", "Other information": "Each teaspoon (5 mL) contains: sodium 3 mg Store between 15°-30°C (59°-86°F) Protect from freezing. Protect from light", "Directions - 60 ml": "this product does not contain directions or complete warnings for adult use do not give more than directed (see overdose warning) shake well before using mL= milliliter find right dose on chart below, if posible, use weight to dose; otherwise, use age only use enclosed measuring syringe repeat dose ebery 4 hours while symptoms last do not give more than 5 times in 24 hours Weight (lb) Age (yr) Dose (mL) * under 24 under 2 years ask a doctor 24-35 2-3 years 5 mL *or as directed by doctor", "Directions - 118 mL": "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 (Ib) Age (yr) 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", "Inactive Ingredients": "acesulfame potassium, avicel, citric acid, FD&C red no. 40, flavor, glycerine, high fructose corn syrup, polysorbate, propylene glycol, prosweet N&AK, purified water, sodium benzoate, sucralose, sorbitol, xanthan gum.", "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 69729-006-04 Temperal-ito", "Active Ingredient(In each 5 mL) Purpose - 60 mL": "Acetaminophen 160 mg..............Pain reliever/fever reducer", "Active Ingredient(in each 5 mL) Purpose - 118 mL": "Acetaminophen 160 mg............. Pain reliever/fever reducer"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:26.777280 · Updated: 2026-03-14T23:05:11.503942