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NDC 00904-7014-16 Children Acetaminophen Oral Solution 160 mg/5mL Details
Children Acetaminophen Oral Solution 160 mg/5mL
Children Acetaminophen Oral Solution is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by MAJOR PHARMACEUTICALS. The primary component is ACETAMINOPHEN.
MedlinePlus Drug Summary
Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to vaccinations (shots), and to reduce fever. Acetaminophen may also be used to relieve the pain of osteoarthritis (arthritis caused by the breakdown of the lining of the joints). Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.
Related Packages: 00904-7014-16Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Acetaminophen
Product Information
| NDC | 00904-7014 |
|---|---|
| Product ID | 0904-7014_5cc2440e-0bee-4d48-9dc7-c4c517838536 |
| Associated GPIs | 64200010002010 |
| GCN Sequence Number | 004484 |
| GCN Sequence Number Description | acetaminophen LIQUID 160 MG/5ML ORAL |
| HIC3 | H3E |
| HIC3 Description | ANALGESIC/ANTIPYRETICS,NON-SALICYLATE |
| GCN | 16932 |
| HICL Sequence Number | 001866 |
| HICL Sequence Number Description | ACETAMINOPHEN |
| Brand/Generic | Generic |
| Proprietary Name | Children Acetaminophen Oral Solution |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Acetaminophen |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LIQUID |
| Route | ORAL |
| Active Ingredient Strength | 160 |
| Active Ingredient Units | mg/5mL |
| Substance Name | ACETAMINOPHEN |
| Labeler Name | MAJOR PHARMACEUTICALS |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH NOT FINAL |
| Application Number | part343 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 00904-7014-16 (00904701416)
| NDC Package Code | 0904-7014-16 |
|---|---|
| Billing NDC | 00904701416 |
| Package | 473 mL in 1 BOTTLE (0904-7014-16) |
| Marketing Start Date | 2019-10-01 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.01368 |
| Pricing Unit | ML |
| Effective Date | 2024-02-21 |
| NDC Description | CHLD ACETAMINOPHEN 160 MG/5 ML |
| Pharmacy Type Indicator | C/I |
| OTC | Y |
| Explanation Code | 1, 5 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |
Standard Product Labeling (SPL)/Prescribing Information SPL cfca5147-f390-40bd-8f13-c5b3b8d1c5b0 Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
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
Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
If a skin reaction occurs, stop use and seek medical help right away.
Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Ask a doctor before use if you have liver disease.
Ask a doctor before use if you are 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 10 days in adults
- pain gets worse or lasts more than 5 days in children under 12 years
- 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.
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Directions
- do not take more than directed
- find dose in chart below
- if possible, use weight to dose, otherwise use age
- dosage may be repeasted every 4 hours, or as directed by a doctor
- do not give more than 5 doses in 24 hours
| Weight (lbs) | under 24 | 24-35 | 36-47 | 48-59 | 60-71 | 72-95 | over 95 |
| Age (years) | under 2 | 2 to 3 | 4 to 5 | 6 to 8 | 9 to 10 | 11 | 12 to adult |
| Dosage Teaspoonful (tsp) | consult Physician | 1 tsp (5 mL) | 1 1/2 tsp (7.5 mL) | 2 tsp (10 mL) | 2 1/2 tsp (12.5 mL) | 3 tsp (15 mL) | 4 tsp (20 mL) |
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
| CHILDREN ACETAMINOPHEN ORAL SOLUTION
acetaminophen liquid |
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| Labeler - MAJOR PHARMACEUTICALS (191427277) |