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NDC 49035-0315-08 Day and Night Cold and Flu Formula Details
Day and Night Cold and Flu Formula
Day and Night Cold and Flu Formula is a KIT in the HUMAN OTC DRUG category. It is labeled and distributed by Wal-Mart Stores Inc. The primary component is .
Product Information
| NDC | 49035-0315 |
|---|---|
| Product ID | 49035-315_6511bedc-9275-4b4d-be3a-0d90d5414605 |
| 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 | Day and Night Cold and Flu Formula |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | KIT |
| Route | n/a |
| Active Ingredient Strength | n/a |
| Active Ingredient Units | n/a |
| Substance Name | n/a |
| Labeler Name | Wal-Mart Stores Inc |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 49035-0315-08 (49035031508)
| NDC Package Code | 49035-315-08 |
|---|---|
| Billing NDC | 49035031508 |
| Package | 1 KIT in 1 CARTON (49035-315-08) * 1 BLISTER PACK in 1 CARTON / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK |
| Marketing Start Date | 2017-08-23 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 1da4f520-34ab-4e8b-b302-a05fbe2c15d6 Details
Non-Drowsy Day Cold and Flu Active ingredients (in each softgel)
Night Cold and FluActive ingredients (in each softgel)
Purposes
Uses
Uses
DAY COLD & FLU FORMULAWarnings
Liver warning
These products contain acetaminophen. Severe liver damage may occur if you take
- more than 10 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 product
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.
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.
- 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.
- if you have ever had an allergic reaction to this product or any of its ingredients
- in children under 12 years of age
Ask a doctor before use if you have
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- cough with excessive phlegm (mucus)
- difficulty in urination due to enlargement of the prostate gland
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
Stop use and ask a doctor if
- pain, cough, or nasal congestion 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.
- nervousness, dizziness, or sleeplessness occurs
NIGHTTIME COLD & FLU FORMULAWarnings
Liver warning
These products contain acetaminophen. Severe liver damage may occur if you take
- more than 10 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 product
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.
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 to sedate children.
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.
- if you have ever had an allergic reaction to this product or any of its ingredients
- in children under 12 years of age
Ask a doctor before use if you have
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- glaucoma
- cough with excessive phlegm (mucus)
- a breathing problem such as emphysema or chronic bronchitis
- difficulty in urination due to enlargement of the prostate gland
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
When using this product
- do not exceed recommended dosage
- may cause marked drowsiness
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- excitability may occur, especially in children
Stop use and ask a doctor if
- pain, cough, or nasal congestion 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.
- nervousness, dizziness, or sleeplessness occurs
DAY COLD & FLU FORMULADirections
NIGHTTIME COLD & FLU FORMULADirections
NIGHTTIME COLD & FLU FORMULAOther information
DAY COLD & FLU FORMULAInactive ingredients
NIGHTTIME COLD & FLU FORMULAInactive ingredients
Principal Display Panel - Carton Label
INGREDIENTS AND APPEARANCE
| DAY AND NIGHT COLD AND FLU FORMULA
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride kit |
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| Labeler - Wal-Mart Stores Inc (051957769) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd | 421293287 | manufacture(49035-315) , analysis(49035-315) | |
Revised: 11/2019
Document Id: 6511bedc-9275-4b4d-be3a-0d90d5414605
Set id: 1da4f520-34ab-4e8b-b302-a05fbe2c15d6
Version: 2
Effective Time: 20191121