Indications and uses
temporarily: reduces fever relieves minor aches and pains due to: sore throat the common cold flu headache toothache
Temperal-ito
- Manufacturer
- OPMX Chula Vista
- Effective date
- 2026-09-24
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 7
- Source
- daily-update
- Hydrated at
- 2026-09-30 01:02:07
Label at a glance#
ProductTemperal-ito
Active ingredientACETAMINOPHEN
Label structure24 sections
Dosage and administration
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...
Storage and handling
Each teaspoon (5 mL) contains: sodium 3 mg Store between 15°-30°C (59°-86°F) Protect from freezing. Protect from light
Contacts and useful links#
Label contents#
Full prescribing information#
Active Ingredient(in each 5 mL) Purpose - 118 mL
Acetaminophen 160 mg............. Pain reliever/fever reducer
OTC - PURPOSE SECTION
Pain Reliever & Fever Reducer
Uses
temporarily:
- reduces fever
- relieves minor aches and pains due to:
- sore throat
- the common cold
- flu
- headache
- toothache
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.
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.
OTC - ASK DOCTOR SECTION
Ask a doctor before use if your child has liver disease.
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin.
OTC - WHEN USING SECTION
When using this product do not exceed recommened dose (see overdose warning)
OTC - STOP USE SECTION
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
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
OVERDOSAGE SECTION
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.
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 |
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
Active Ingredient(In each 5 mL) Purpose - 60 mL
Acetaminophen 160 mg..............Pain reliever/fever reducer
Purpose
Pain Reliever & Fever Reducer
Uses
temporarily:
- reduces fever
- relieves minor aches and pains due to:
- the common cold
- headache
- flu
- sore throat
- toothache
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.
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.
OTC - ASK DOCTOR SECTION
Ask a doctor before use if your child has liver disease
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin.
OTC - WHEN USING SECTION
When using this product do not exceed recommened dose (see overdose warning)
OTC - STOP USE SECTION
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
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep Out Of Reach Of Children
OVERDOSAGE SECTION
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.
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
Other Information
- store between 20°-25°C (68°-77°F)
- protect from freezing
- protect from light
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.
Questions or comments?
Call toll free 619-600-5632
Monday through Fnday 9AM - 5PM EST
PRINCIPAL DISPLAY PANEL
NDC 69729-006-04 Temperal-ito
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 69729-006-02
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0810053180839 | GTIN-13: 0810053180839 EAN-13: 0810053180839 GTIN-12: 810053180839 UPC-A: 810053180839 GTIN storage (14 digits): 00810053180839 | Temperal-ito Infant Fever 2floz.jpg |
| Barcode | EAN-13 | 0810053181157 | GTIN-13: 0810053181157 EAN-13: 0810053181157 GTIN-12: 810053181157 UPC-A: 810053181157 GTIN storage (14 digits): 00810053181157 | Children Fever Temperalito 4 floz.jpg |
Products#
Every source-derived product name is available through these pages.
- Temperal-ito
- Acetaminophen
- 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
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 69729-006 | 69729-006-04, 69729-006-02 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 6 | 2024-11-15 | full-release | 2026-06-01 00:37:38 |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Temperal-ito | ACETAMINOPHEN | OPMX Chula Vista | fd2d85a0-4bc6-3ed0-e053-6294a90a8494 | 2024-11-15 | Warnings | 69729-006-02 69729-006-04 69729-006 69729000602 69729000604 fd2d85a0-4bc6-3ed0-e053-6294a90a8494 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.