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NDC 63868-0290-06 Severe Cold and Cough Daytime 650; 20; 10 mg/1; mg/1; mg/1 Details
Severe Cold and Cough Daytime 650; 20; 10 mg/1; mg/1; mg/1
Severe Cold and Cough Daytime is a ORAL POWDER, FOR SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Chain Drug Manufacturing Assn. The primary component is ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE.
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: 63868-0290-06Last 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: 63868-0290-06Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Dextromethorphan
Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Phenylephrine is in a class of medications called nasal decongestants. It works by reducing swelling of the blood vessels in the nasal passages.
Related Packages: 63868-0290-06Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 63868-0290 |
|---|---|
| Product ID | 63868-290_3c291770-4524-474a-ad3f-4fc34416f754 |
| 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 | Severe Cold and Cough Daytime |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | POWDER, FOR SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 650; 20; 10 |
| Active Ingredient Units | mg/1; mg/1; mg/1 |
| Substance Name | ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE |
| Labeler Name | Chain Drug Manufacturing Assn |
| Pharmaceutical Class | Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | 2023-12-31 |
Package
Package Images
NDC 63868-0290-06 (63868029006)
| NDC Package Code | 63868-290-06 |
|---|---|
| Billing NDC | 63868029006 |
| Package | 6 PACKET in 1 CARTON (63868-290-06) / 1 POWDER, FOR SOLUTION in 1 PACKET |
| Marketing Start Date | 2018-07-25 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 26d2d39a-6d37-45d9-a4f9-4015cc97158b Details
Active ingredients (in each packet)
Uses
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- ▪
- more than 4,000 mg of acetaminophen in 24 hours
- ▪
- with other drugs containing acetaminophen
- ▪
- 3 or more alcoholic drinks every day 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
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
- ▪
- in a child under 12 years of age
- ▪
- if you are allergic to acetaminophen
- ▪
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or a pharmacist.
- ▪
- if you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask doctor before use if you have
- ▪
- liver disease
- ▪
- heart disease
- ▪
- high blood pressure
- ▪
- thyroid disease
- ▪
- diabetes
- ▪
- trouble urinating due to an enlarged prostate gland
- ▪
- cough that occurs with too much phlegm (mucus)
- ▪
- cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
Stop use and ask a doctor if
- ▪
- nervousness, dizziness, or sleeplessness occurs
- ▪
- fever gets worse or lasts more than 3 days
- ▪
- redness or swelling is present
- ▪
- new symptoms occur
- ▪
- symptoms do not get better or worsen
- ▪
- pain, cough or nasal congestion gets worse or lasts more than 7 days
- ▪
- cough comes back or occurs fever, rash or headache that lasts. These could be signs of a serious condition.
Directions
- ▪
- do not use more than directed
- ▪
- take every 4 hours; while symptoms persist. Do not to exceed 5 packets in 24 hours unless directed by a doctor
|
Age |
Dose |
|
Adults and children 12 years of age and over |
One packet |
|
Children under 12 years of age |
Do not use |
- •
- dissolve contents of one packet into 8 oz hot water; sip while hot. Consume entire drink within 10-15 minutes
- •
- If using a microwave, add contents of one packet 8 oz. of cool water: Stir briskly before and after heating: Do not overheat.
Other information
Inactive ingredients
Principal Display
QC Quality Choice
*Compare to the Active Ingredients in Theraflu® Daytime Severe Cold &Cough
SEVERE COLD & COUGH
Daytime
Acetaminophen
Pain Reliever/ Fever Reducer
Dextromethorphan HBr
Cough suppressant
Phenylephrine HCl
Nasal Decongestant
Aspartame Free ●Sodium Free
Relieves:
- Nasal Congestion
- Cough/Body Ache
- Sore Throat Pain
- Headache/Fever
Berry Infused with Menthol & Green Tea Flavors
6 Packets
|
READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE, KEEP CARTON FOR REFERENCE, DO NOT DISCARD, |
*This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Theraflu® Daytime Severe Cough & Cold
TAMPER EVIDENT INNER UNIT: DO NOT USE IF SEALED PACKET IS TORN OR BROKEN.
Distributed by: C.D.M.A., Inc
43157 W. 9 Mile Rd
Novi, MI 48375
Questions: 248-449-9300
INGREDIENTS AND APPEARANCE
| SEVERE COLD AND COUGH DAYTIME
acetaminophen, dextromethorphan, phenylephrine powder, for solution |
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| Labeler - Chain Drug Manufacturing Assn (011920774) |