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NDC 63824-0222-64 Childrens Delsym 325; 10 mg/10mL; mg/10mL Details
Childrens Delsym 325; 10 mg/10mL; mg/10mL
Childrens Delsym is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by RB Health (US) LLC. The primary component is ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE.
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: 63824-0222-64Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Acetaminophen
Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.
Related Packages: 63824-0222-64Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Dextromethorphan
Product Information
| NDC | 63824-0222 |
|---|---|
| Product ID | 63824-222_ff8f9e20-eb76-4182-8ca4-afcb99df8a1a |
| Associated GPIs | 43995502200904 |
| GCN Sequence Number | 080839 |
| GCN Sequence Number Description | acetaminophen/dextromethorphan LIQUID 325-10/10 ORAL |
| HIC3 | B4A |
| HIC3 Description | NON-OPIOID ANTITUSSIVE-ANALGESIC COMBINATIONS |
| GCN | 47821 |
| HICL Sequence Number | 006331 |
| HICL Sequence Number Description | ACETAMINOPHEN/DEXTROMETHORPHAN HBR |
| Brand/Generic | Brand |
| Proprietary Name | Childrens Delsym |
| Proprietary Name Suffix | Cough Plus Sore Throat |
| Non-Proprietary Name | Acetaminophen and Dextromethorphan Hydrobromide |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 325; 10 |
| Active Ingredient Units | mg/10mL; mg/10mL |
| Substance Name | ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE |
| Labeler Name | RB Health (US) LLC |
| Pharmaceutical Class | Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | 2023-12-31 |
Package
Package Images
NDC 63824-0222-64 (63824022264)
| NDC Package Code | 63824-222-64 |
|---|---|
| Billing NDC | 63824022264 |
| Package | 1 BOTTLE in 1 CARTON (63824-222-64) / 118 mL in 1 BOTTLE |
| Marketing Start Date | 2019-07-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 709ad404-f45e-4cfd-9797-9c9f84425996 Details
SPL UNCLASSIFIED SECTION
Uses
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.
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.
- in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
Ask a doctor before use if the child has
- liver disease
- persistent or chronic cough such as occurs with asthma
- cough that occurs with too much phlegm (mucus)
When using this product do not use more than directed (see Overdose warning)
Directions
- this product does not contain directions or complete warnings for adult use
- do not give more than directed (see Overdose warning)
- measure only with dosing cup provided
- do not use dosing cup with other products
- dose as follows or as directed by a doctor
- children 6 to under 12 years of age: 10 mL in dosing cup provided every 4 hours while symptoms last; do not give more than 5 doses in any 24-hour period
- children under 6 years of age: do not use
Inactive ingredients
PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton
INGREDIENTS AND APPEARANCE
| CHILDRENS DELSYM
COUGH PLUS SORE THROAT
acetaminophen and dextromethorphan hydrobromide solution |
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| Labeler - RB Health (US) LLC (081049410) |