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NDC 00067-8132-08 Theraflu ExpressMax Severe Cold and Flu Syrup 650; 20; 400; 10 mg/1; mg/1; mg/1; mg/1 Details
Theraflu ExpressMax Severe Cold and Flu Syrup 650; 20; 400; 10 mg/1; mg/1; mg/1; mg/1
Theraflu ExpressMax Severe Cold and Flu Syrup is a ORAL SYRUP 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; GUAIFENESIN; 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: 00067-8132-08Last 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: 00067-8132-08Last 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: 00067-8132-08Last 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: 00067-8132-08Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 00067-8132 |
|---|---|
| Product ID | 0067-8132_777d2ac7-e3cc-4513-8b6f-b90b2ff2c672 |
| Associated GPIs | 43998304100910 |
| GCN Sequence Number | 061341 |
| GCN Sequence Number Description | phenylephrine/DM/acetaminop/GG LIQUID 5-325MG/15 ORAL |
| HIC3 | B4P |
| HIC3 Description | NON-OPIOID ANTITUSS-DECONGESTANT-ANALGESIC-EXPECT |
| GCN | 97133 |
| HICL Sequence Number | 035445 |
| HICL Sequence Number Description | PHENYLEPHRINE HCL/DEXTROMETHORPHAN HBR/ACETAMINOPHEN/GUAIFEN |
| Brand/Generic | Generic |
| Proprietary Name | Theraflu ExpressMax Severe Cold and Flu Syrup |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SYRUP |
| Route | ORAL |
| Active Ingredient Strength | 650; 20; 400; 10 |
| Active Ingredient Units | mg/1; mg/1; mg/1; mg/1 |
| Substance Name | ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; 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 00067-8132-08 (00067813208)
| NDC Package Code | 0067-8132-08 |
|---|---|
| Billing NDC | 00067813208 |
| Package | 1 SYRUP in 1 BOTTLE (0067-8132-08) |
| Marketing Start Date | 2017-07-07 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 777d2ac7-e3cc-4513-8b6f-b90b2ff2c672 Details
Active ingredients (in each 30 mL)
Uses
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- temporarily relieves these symptoms due to a cold:
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- minor aches and pains
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- minor sore throat pain
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- headache
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- nasal and sinus congestion
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- cough due to minor throat and bronchial irritation
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- temporarily reduces fever
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- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
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- more than 4,000 mg of acetaminophen in 24 hours
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- with other drugs containing acetaminophen
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- 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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- skin reddening
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- blisters
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- 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
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- in a child under 12 years of age
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- if you are allergic to acetaminophen
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- 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
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- liver disease
- •
- heart disease
- •
- high blood pressure
- •
- thyroid disease
- •
- diabetes
- •
- trouble urinating due to an enlarged prostate gland
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- cough that occurs with too much phlegm (mucus)
- •
- cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema
Stop use and ask a doctor if
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- nervousness, dizziness, or sleeplessness occurs
- •
- fever gets worse or lasts more than 3 days
- •
- redness or swelling is present
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- new symptoms occur
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- 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
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- do not use more than directed
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- measure the dose correctly using the enclosed dosing cup
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- 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
Package/Label Principal Display Panel
NDC 0067-8132-08
Theraflu®Expressmax™
SEVERE COLD AND FLU
ACETAMINOPHEN- PAIN RELIEVER/ FEVER REDUCER
DEXTROMETHORPHAN HBr- COUGH SUPPRESSANT
GUAIFENESIN- EXPECTORANT
PHENYLEPHRINE HCl- NASAL DECONGESTANT
- •
- BODY ACHE
- •
- FEVER
- •
- CHEST CONGESTION
- •
- NASAL CONGESTION
- •
- HEADACHE
- •
- COUGH
- •
- SORE THROAT PAIN
ALCOHOL FREE
BERRY FLAVOR 8.3 FL OZ (245.5 mL)
- PARENTS:
- Learn about teen medicine abuse
- www.StopMedicineAbuse.org
- *Maximum Strength per 4 hour dose.
- Distributed by: GSK Consumer Healthcare, Warren, NJ 07059
- Trademarks are owned or licensed to the GSK group of companies.
- © 2016 GSK group of companies or its licensor. All rights reserved.
INGREDIENTS AND APPEARANCE
| THERAFLU EXPRESSMAX SEVERE COLD AND FLU SYRUP
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl syrup |
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| Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC. (079944263) |
| Registrant - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC. (079944263) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Mallinckrodt, Inc. | 097722284 | API MANUFACTURE(0067-8132) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| DIVI's Laboratories Limited | 918598199 | API MANUFACTURE(0067-8132) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Granules India Limited | 918457644 | API MANUFACTURE(0067-8132) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Iwaki Seiyaku Co. Ltd | 711708664 | API MANUFACTURE(0067-8132) | |