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NDC 00363-0109-24 DAYTIME COLD AND FLU 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 Details
DAYTIME COLD AND FLU 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1
DAYTIME COLD AND FLU is a ORAL CAPSULE, LIQUID FILLED in the HUMAN OTC DRUG category. It is labeled and distributed by Walgreens. The primary component is ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE.
MedlinePlus Drug Summary
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: 00363-0109-24Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Dextromethorphan
Guaifenesin is used to relieve chest congestion. Guaifenesin may help control symptoms but does not treat the cause of symptoms or speed recovery. Guaifenesin is in a class of medications called expectorants. It works by thinning the mucus in the air passages to make it easier to cough up the mucus and clear the airways.
Related Packages: 00363-0109-24Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Guaifenesin
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: 00363-0109-24Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 00363-0109 |
|---|---|
| Product ID | 0363-0109_e1da2d60-fa36-8486-e053-2a95a90a1bad |
| Associated GPIs | 46200010005205 |
| GCN Sequence Number | 002944 |
| GCN Sequence Number Description | bisacodyl SUPP.RECT 10 MG RECTAL |
| HIC3 | Q3S |
| HIC3 Description | LAXATIVES, LOCAL/RECTAL |
| GCN | 08731 |
| HICL Sequence Number | 001301 |
| HICL Sequence Number Description | BISACODYL |
| Brand/Generic | Generic |
| Proprietary Name | DAYTIME COLD AND FLU |
| Proprietary Name Suffix | Maximum Strength |
| Non-Proprietary Name | ACETAMINOPHEN, DEXTROMETHORPHAN HBr,GUAIFENESIN, PHENYLEPHRINE HCl |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | CAPSULE, LIQUID FILLED |
| Route | ORAL |
| Active Ingredient Strength | 325; 10; 200; 5 |
| Active Ingredient Units | mg/1; mg/1; mg/1; mg/1 |
| Substance Name | ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE |
| Labeler Name | Walgreens |
| Pharmaceutical Class | Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 00363-0109-24 (00363010924)
| NDC Package Code | 0363-0109-24 |
|---|---|
| Billing NDC | 00363010924 |
| Package | 2 BLISTER PACK in 1 CARTON (0363-0109-24) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK |
| Marketing Start Date | 2022-06-23 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL dbf5656b-9105-871b-e053-2995a90a4941 Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Uses
temporarily relieves common cold/flu symptoms:
• nasal congestion
• sinus congestion & pressure
• cough due to minor throat & bronchial irritation
• minor aches & pains
• headache
• fever
• sore throat
• reduces swelling of nasal passages
• temporarily restores freer breathing through the nose
• promotes nasal and/or sinus drainage
• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.
SPL UNCLASSIFIED SECTION
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
• more than 8 softgels in 24 hours, which is the maximum daily amount for this product
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this produc
t
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.
• 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 a doctor before use if you have
• liver disease
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to enlarged prostate gland
• cough that occurs with too much phlegm (mucus)
• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
Stop use and ask a doctor if
• you get nervous, dizzy or sleepless
• pain, nasal congestion or cough gets worse or lasts more than 7 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• new symptoms occur
• cough comes back or occurs with rash or headache that lasts.
These could be signs of a serious condition.
SPL UNCLASSIFIED SECTION
Directions
- take only as directed
- do not exceed 8 softgels per 24 hours
| adults & children 12 years & over | 2 softgels with water every 4 hours |
| children 4 to under 12 years | ask a doctor |
| children under 4 years | do not use |
- When using other Nighttime or Daytime products, carefully read each label to ensure correct dosing.
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
| DAYTIME COLD AND FLU
MAXIMUM STRENGTH
acetaminophen, dextromethorphan hbr,guaifenesin, phenylephrine hcl capsule, liquid filled |
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| Labeler - Walgreens (008965063) |
| Registrant - TIME CAP LABORATORIES INC. (037052099) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| MARKSANS PHARMA LIMITED | 925822975 | manufacture(0363-0109) | |