Search by Drug Name or NDC
NDC 63868-0678-60 ACETAMINOPHEN 160 mg/5mL Details
ACETAMINOPHEN 160 mg/5mL
ACETAMINOPHEN is a ORAL SUSPENSION in the HUMAN OTC DRUG category. It is labeled and distributed by CHAIN DRUG MARKETING ASSOCIATION INC. 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: 63868-0678-60Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Acetaminophen
Product Information
NDC | 63868-0678 |
---|---|
Product ID | 63868-678_b1b052c8-0b66-43c8-9551-e265b618022a |
Associated GPIs | |
GCN Sequence Number | n/a |
GCN Sequence Number Description | n/a |
HIC3 | n/a |
HIC3 Description | n/a |
GCN | n/a |
HICL Sequence Number | n/a |
HICL Sequence Number Description | n/a |
Brand/Generic | n/a |
Proprietary Name | ACETAMINOPHEN |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | ACETAMINOPHEN |
Product Type | HUMAN OTC DRUG |
Dosage Form | SUSPENSION |
Route | ORAL |
Active Ingredient Strength | 160 |
Active Ingredient Units | mg/5mL |
Substance Name | ACETAMINOPHEN |
Labeler Name | CHAIN DRUG MARKETING ASSOCIATION INC |
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 63868-0678-60 (63868067860)
NDC Package Code | 63868-678-60 |
---|---|
Billing NDC | 63868067860 |
Package | 60 mL in 1 BOTTLE (63868-678-60) |
Marketing Start Date | 2021-02-01 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL cfc7eac3-35be-4002-b8ef-be1dfc8caf69 Details
Active Ingredient Purpose(in each 5 mL)
Uses temporarily:
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
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.
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.
When using this product do not exceed recommended dose (see overdose warning)
Do not use
SPL UNCLASSIFIED SECTION
Stop use and ask a doctor if
SPL UNCLASSIFIED 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 1-800-222-1222. 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.
- do not give more than directed (see overdose warning)
- shake well before using
- ml= milliliter
- find right dose on chart below.
If possible, use weight to dose; otherwise, use age.
- only use enclosed measuring syringe
- repeat dose every 4 hours while symptoms last
- do not give more than 5 times in 24 hours
Other information
Inactive ingredients
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
ACETAMINOPHEN
acetaminophen suspension |
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
Labeler - CHAIN DRUG MARKETING ASSOCIATION INC (011920774) |
Registrant - Seaway Pharma Inc. (117218785) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Seaway Pharma Inc. | 117218785 | manufacture(63868-678) |