Indications and uses
temporarily: reduces fever relieves minor aches and pains due to: the common cold flu headache sore throat toothache
Childrens Acetaminophen
- Manufacturer
- We Care Distributor Inc. | PURINE PHARMA LLC
- Effective date
- 2016-10-13
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-05-31 22:47:34
Label at a glance#
ProductChildrens Acetaminophen
Active ingredientAcetaminophen
Label structure9 sections
Dosage and administration
this product does not contain directions or complete warnings for adult use. shake well before using mL = milliliter find right dose on chart below. If possible, use weight to dose; otherwise, use age. repeat dose every 4 hours while symptoms last 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...
Storage and handling
each teaspoon (5 mL) contains : sodium 7 mg Store at room temperature 15º - 30ºC (59º - 86ºF) Protect from Freezing. Protect from Light. TAMPER EVIDENT: DO NOT USE THIS PRODUCT IF PRINTED INNER CAP SEAL IS BROKEN OR MISSING
Contacts and useful links#
Websitewww.wecaredistributor.com
www.wecaredistributor.com
www.wecaredistributor.comLabel contents#
Full prescribing information#
Active ingredient (in each 5 mL)
Acetaminophen 160 mg
Purpose
Pain reliever/Fever reducer
Uses
temporarily:
- reduces fever
- relieves minor aches and pains due to:
the common cold
flu
headache
sore throat
toothache
Warnings
Liver warning:
This product contains acetaminophen. Severe liver damage may occur if your child 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 (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
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 recommended dose (see overdose warning)
Stop use and ask a doctor if
- new symptoms 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.
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
- this product does not contain directions or complete warnings for adult use.
- shake well before using
- mL = milliliter
- find right dose on chart below. If possible, use weight to dose; otherwise, use age.
- repeat dose every 4 hours while symptoms last
- 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
Other information
- each teaspoon (5 mL) contains: sodium 7 mg
- Store at room temperature 15º - 30ºC (59º - 86ºF)
- Protect from Freezing.
- Protect from Light.
- TAMPER EVIDENT: DO NOT USE THIS PRODUCT IF PRINTED INNER CAP SEAL IS BROKEN OR MISSING
Inactive ingredients
citric acid, FD&C red # 40, FD&C blue # 1, flavor, glycerin. PEG 400, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol
QUESTIONS OR COMMENTS
1-888-705-WECARE (Mon-Fri 9am-5pm EST) or www.wecaredistributor.com
PRINCIPAL DISPLAY PANEL
*Compare to the active ingredient in Children's Tylenol® Elixir
Children's Acetaminophen Elixir
Grape Flavor
For ages 2 to 11
2 FL OZ (60 mL)
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 307668 | acetaminophen 160 MG in 5 mL Oral Suspension | PSN | 2 |
| 307668 | acetaminophen 32 MG/ML Oral Suspension | SCD | 2 |
| 307668 | acetaminophen 160 MG per 5 ML Oral Suspension | SY | 2 |
| 307668 | acetaminophen 320 MG per 10 ML Oral Suspension | SY | 2 |
| 307668 | acetaminophen 650 MG per 20.3 ML Oral Suspension | SY | 2 |
| 307668 | acetaminophen 80 MG per 2.5 ML Oral Suspension | SY | 2 |
| 307668 | APAP 32 MG/ML Oral Suspension | SY | 2 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 70005-049-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-dddb-f424-e053-dadaa90a57ce | Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70005-049-01 | Childrens Acetaminophen | 60 mL in 1 BOTTLE | ELIXIR | 60 | 2 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Childrens Acetaminophen
- Acetaminophen
- ANHYDROUS CITRIC ACID
- FD&C RED NO. 40
- FD&C BLUE NO. 1
- GLYCERIN
- POLYETHYLENE GLYCOL 400
- SODIUM BENZOATE
- SODIUM CITRATE
- SACCHARIN SODIUM
- SORBITOL
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 70005-049 | 70005-049-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Acetaminophen | 362O9ITL9D | ACTIB |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SODIUM CITRATE | 1Q73Q2JULR | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| SORBITOL | 506T60A25R | IACT |
| WATER | 059QF0KO0R | IACT |
Source Document#
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 |
|---|---|---|---|---|---|---|
| 4f1786d3-3dc7-4e27-90c6-7b543e81c131 | 3c1c1832-a1c9-4a72-93b2-27b7b8e64ec5 | 2016-10-13 | Warnings | 4f1786d3-3dc7-4e27-90c6-7b543e81c131 3c1c1832-a1c9-4a72-93b2-27b7b8e64ec5 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.