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NDC 00067-8125-16 Theraflu ExpressMax Details
Theraflu ExpressMax
Theraflu ExpressMax is a KIT in the HUMAN OTC DRUG category. It is labeled and distributed by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC. The primary component is .
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: 00067-8125-16Last Updated: 11/30/2022
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: 00067-8125-16Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Dextromethorphan
Diphenhydramine is used to relieve red, irritated, itchy, watery eyes; sneezing; and runny nose caused by hay fever, allergies, or the common cold. Diphenhydramine is also used to relieve cough caused by minor throat or airway irritation. Diphenhydramine is also used to prevent and treat motion sickness, and to treat insomnia (difficulty falling asleep or staying asleep). Diphenhydramine is also used to control abnormal movements in people who have early stage parkinsonian syndrome (a disorder of the nervous system that causes difficulties with movement, muscle control, and balance) or who are experiencing movement problems as a side effect of a medication. Diphenhydramine will relieve the symptoms of these conditions but will not treat the cause of the symptoms or speed recovery. Diphenhydramine should not be used to cause sleepiness in children. Diphenhydramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.
Related Packages: 00067-8125-16Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Diphenhydramine
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: 00067-8125-16Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 00067-8125 |
|---|---|
| Product ID | 0067-8125_5752247a-a951-49c8-b52a-2b7f387e4fbe |
| 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 | Theraflu ExpressMax |
| Proprietary Name Suffix | Daytime Nighttime Value Pack |
| Non-Proprietary Name | Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl and Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl |
| 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 | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC |
| 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 00067-8125-16 (00067812516)
| NDC Package Code | 0067-8125-16 |
|---|---|
| Billing NDC | 00067812516 |
| Package | 1 KIT in 1 CARTON (0067-8125-16) * 245.5 mL in 1 BOTTLE (0067-8127-08) * 245.5 mL in 1 BOTTLE (0067-8129-08) |
| Marketing Start Date | 2015-07-15 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 9736ad4c-8c2e-421f-b023-f91b72d2828b Details
Active ingredients (in each 30 mL)
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 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 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
- •
- pain, cough or nasal congestion gets worse or lasts more than 7 days
- •
- cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
Directions
- •
- do not use more than directed
- •
- measure the dose correctly using the enclosed dosing cup
- •
- take every 4 hours in dosing cup provided, while symptoms persist
- •
- do not take more than 5 doses (150 mL) in 24 hours unless directed by a doctor
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Other information
Inactive ingredients
Active ingredients (in each 30 mL)
Uses
- •
- temporarily relieves these symptoms due to a cold:
- •
- minor aches and pains
- •
- minor sore throat pain
- •
- headache
- •
- nasal and sinus congestion
- •
- runny nose
- •
- sneezing
- •
- itchy nose or throat
- •
- itchy, watery eyes due to hay fever
- •
- cough due to minor throat and bronchial irritation
- •
- temporarily reduces fever
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 pharmacist.
- •
- with any other product containing diphenhydramine, even one used on the skin
- •
- 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 a MAO, 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
- •
- glaucoma
- •
- trouble urinating due to an enlarged prostate gland
- •
- a breathing problem such as emphysema or chronic bronchitis
- •
- cough that occurs with too much phlegm (mucus)
- •
- cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema
Ask a doctor or pharmacist before use if you are
- •
- taking sedatives or tranquilizers
- •
- taking the blood thinning drug warfarin
When using this product
- •
- do not exceed recommended dosage
- •
- avoid alcoholic drinks
- •
- marked drowsiness may occur
- •
- 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
- •
- nervousness, dizziness, or sleeplessness occurs
- •
- fever gets worse or lasts more than 3 days
- •
- redness or swelling is present
- •
- new symptoms occur
- •
- pain, cough or nasal congestion gets worse or lasts more than 7 days
- •
- cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
Directions
- •
- do not use more than directed
- •
- measure the dose correctly using the enclosed dosing cup
- •
- take every 4 hours in dosing cup provided, while symptoms persist.
- •
- do not take more than 5 doses (150 mL) in 24 hours unless directed by a doctor
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Other information
Inactive ingredients
Other Safety Information
DO NOT TAKE BOTH PRODUCTS AT THE SAME TIME OR TAKE MORE THAN 5 DOSES IN TOTAL IN ANY 24 HOUR PERIOD.
DO NOT TAKE A DOSE OF THE NIGHTTIME PRODUCT SOONER THAN 4 HOURS AFTER THE LAST DOSE OF THE DAYTIME PRODUCT UNLESS DIRECTED BY YOUR DOCTOR.
PARENTS: Learn about teen medicine abuse
TAMPER-EVIDENT INNER UNIT. DO NOT USE IF NECKBAND PRINTED WITH “SEALED FOR SAFETY” IS TORN OR MISSING
Distributed by: GSK Consumer Healthcare
Warren, NJ 07059
©2019 GSK group of companies or its licensor.
13440
Principal Display Panel
NDC 0067-8125-16
THERAFLU
ExpressMax
DAYTIME
SEVERE COLD & COUGH
BERRY FLAVOR
ACETAMINOPHEN
PAIN RELIEVER/FEVER REDUCER
DEXTROMETHORPHAN HBr
COUGH SUPPRESSANT
PHENYLEPHRINE HCl
NASAL DECONGESTANT
• Cough • Nasal Congestion
• Sore Throat Pain • Fever
• Headache • Body Ache
8.3 FL OZ (245.5mL)
Alcohol Free
DAYTIME
THERAFLU
ExpressMax
NIGHTTIME
SEVERE COLD & COUGH
BERRY FLAVOR
ACETAMINOPHEN
PAIN RELIEVER/FEVER REDUCER
DIPHENHYDRAMINE HCl
ANTIHISTAMINE/COUGH SUPPRESSANT
PHENYLEPHRINE HCl
NASAL DECONGESTANT
• Cough • Nasal Congestion
• Sore Throat Pain • Fever
• Headache • Body Ache
• Runny Nose
8.3 FL OZ (245.5mL)
Alcohol Free
NIGHTTIME
- 2 – 8.3 FL OZ (245.5 mL) BOTTLES TOTAL 16.6 FL OZ (491 mL) Use Only As Directed
Principal Display Panel
NDC 0067-8127-08
THERAFLU
ExpressMax
DAYTIME
SEVERE COLD & COUGH
BERRY FLAVOR
ACETAMINOPHEN
PAIN RELIEVER/FEVER REDUCER
DEXTROMETHORPHAN HBr
COUGH SUPPRESSANT
PHENYLEPHRINE HCl
NASAL DECONGESTANT
• Cough • Nasal Congestion
• Sore Throat Pain • Fever
• Headache • Body Ache
8.3 FL OZ (245.5mL)
Alcohol Free
Principal Display Panel
NDC 0067-8129-08
THERAFLU
ExpressMax
NIGHTTIME
SEVERE COLD & COUGH
BERRY FLAVOR
ACETAMINOPHEN
PAIN RELIEVER/FEVER REDUCER
DIPHENHYDRAMINE HCl
ANTIHISTAMINE/COUGH SUPPRESSANT
PHENYLEPHRINE HCl
NASAL DECONGESTANT
• Cough • Nasal Congestion
• Sore Throat Pain • Fever
• Headache • Body Ache
• Runny Nose
8.3 FL OZ (245.5mL)
Alcohol Free
INGREDIENTS AND APPEARANCE
| THERAFLU EXPRESSMAX
DAYTIME NIGHTTIME VALUE PACK
acetaminophen, dextromethorphan hbr, phenylephrine hcl and acetaminophen, diphenhydramine hcl, phenylephrine hcl kit |
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| Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Divi's Laboratories | 918598199 | API MANUFACTURE(0067-8125, 0067-8127, 0067-8129) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Iwaki Seiyaku Co., LTD | 711708664 | API MANUFACTURE(0067-8125, 0067-8127, 0067-8129) | |