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NDC 00067-8136-10 Theraflu ExpressMax 325; 10; 5 mg/1; mg/1; mg/1 Details
Theraflu ExpressMax 325; 10; 5 mg/1; mg/1; mg/1
Theraflu ExpressMax is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC. 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: 00067-8136-10Last 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: 00067-8136-10Last Updated: 11/30/2022
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: 00067-8136-10Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 00067-8136 |
|---|---|
| Product ID | 0067-8136_0b77b02d-9a4a-4208-a291-c829d9655bba |
| Associated GPIs | 43996903400320 |
| GCN Sequence Number | 060981 |
| GCN Sequence Number Description | d-methorphan/PE/acetaminophen TABLET 10-5-325MG ORAL |
| HIC3 | B4M |
| HIC3 Description | NON-OPIOID ANTITUSSIVE-DECONGESTANT-ANALGESIC COMB |
| GCN | 27135 |
| HICL Sequence Number | 008885 |
| HICL Sequence Number Description | DEXTROMETHORPHAN HBR/PHENYLEPHRINE HCL/ACETAMINOPHEN |
| Brand/Generic | Generic |
| Proprietary Name | Theraflu ExpressMax |
| Proprietary Name Suffix | Daytime Severe Cold and Cough |
| Non-Proprietary Name | acetaminophen, dextromethorphan HBr, phenylephrine HCl |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 325; 10; 5 |
| Active Ingredient Units | mg/1; mg/1; mg/1 |
| Substance Name | ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE |
| Labeler Name | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC |
| 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 | 2024-12-31 |
Package
Package Images
NDC 00067-8136-10 (00067813610)
| NDC Package Code | 0067-8136-10 |
|---|---|
| Billing NDC | 00067813610 |
| Package | 1 BLISTER PACK in 1 CARTON (0067-8136-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK |
| Marketing Start Date | 2017-06-08 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL f6ae9e3a-6bea-40e0-8a6f-45f4be8319e7 Details
Uses
Warnings
Liver warning: This product contains acetaminophen. Severe lever 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
Inactive ingredients
benzoic acid, carmine, croscarmellose sodium, ethanol, ferric oxide yellow, flavors, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polysorbate 60, polysorbate 80, povidone, pregelatinized starch, propylene glycol, silicon dioxide, stearic acid, sucralose, titanium dioxide
Principal Display Panel
NDC 0067-8136-20
Theraflu® ExpressMax®
DAYTIME
SEVERE COLD & COUGH
WARMING RELIEF™ FORMULA
ACETAMINOPHEN – PAIN RELIEVER/FEVER REDUCER
DEXTROMETHORPHAN HBr – COUGH SUPPRESSANT
PEHNYLEPHRINE HCl – NASAL DECONGESTANT
- •
- NASAL CONGESTION • SORE THROAT
- •
- HEADACHE • BODY ACHE • COUGH • FEVER
20 COATED CAPLETS
READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE. KEEP CARTON FOR REFERENCE. DO NOT DISCARD.
PARENTS:
Learn about teen medicine abuse
www.StopMedicineAbuse.org
*Maximum Strength per 4 hour dose.
TAMPER EVIDENT FEATURE:
THERAFLU® EXPRESSMAX® CAPLETS ARE SEALED IN BLISTER PACKETS. USE ONLY IF THE INDIVIDUAL SEAL IS UNBROKEN.
Distributed by: GSK Consumer Healthcare, Warren, NJ 07059
Trademarks are owned by or licensed to the GSK group of companies.
©2016 GSK group of companies or its licensor. All rights reserved.
www.theraflu.com
62000000010595
INGREDIENTS AND APPEARANCE
| THERAFLU EXPRESSMAX
DAYTIME SEVERE COLD AND COUGH
acetaminophen, dextromethorphan hbr, phenylephrine hcl tablet, film coated |
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| Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263) |