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NDC 00067-8124-06 Theraflu Nighttime Multi-Symptom Severe Cold Powder 500; 25; 10 mg/1; mg/1; mg/1 Details
Theraflu Nighttime Multi-Symptom Severe Cold Powder 500; 25; 10 mg/1; mg/1; mg/1
Theraflu Nighttime Multi-Symptom Severe Cold Powder is a ORAL POWDER in the HUMAN OTC DRUG category. It is labeled and distributed by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC. The primary component is ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; 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: 00067-8124-06Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Acetaminophen
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: 00067-8124-06Last 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: 00067-8124-06Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 00067-8124 |
|---|---|
| Product ID | 0067-8124_16be0a08-f1de-4da9-a689-c1e71bde4926 |
| Associated GPIs | 43994003903030 |
| 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 Nighttime Multi-Symptom Severe Cold Powder |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | POWDER |
| Route | ORAL |
| Active Ingredient Strength | 500; 25; 10 |
| Active Ingredient Units | mg/1; mg/1; mg/1 |
| Substance Name | ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE |
| Labeler Name | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC |
| Pharmaceutical Class | Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], 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 00067-8124-06 (00067812406)
| NDC Package Code | 0067-8124-06 |
|---|---|
| Billing NDC | 00067812406 |
| Package | 6 POWDER in 1 CARTON (0067-8124-06) |
| Marketing Start Date | 2015-07-15 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL ef42d2a3-1bab-4527-8e1e-54e8749cc7b5 Details
Active ingredients (in each packet)
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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- runny nose
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- sneezing
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- itchy nose or throat
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- itchy, watery eyes due to hay fever
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- cough due to minor throat and bronchial irritation
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- temporarily reduces fever
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.
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- with any other product containing diphenhydramine, even one used on the skin
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- 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
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- heart disease
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- high blood pressure
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- thyroid disease
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- diabetes
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- glaucoma
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- trouble urinating due to an enlarged prostate gland
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- a breathing problem such as emphysema or chronic bronchitis
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- cough that occurs with too much phlegm (mucus)
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- cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
Ask a doctor or pharmacist before use if you are
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- taking sedatives or tranquilizers
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- taking the blood thinning drug warfarin
When using this product
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- do not exceed recommended dosage
- •
- avoid alcoholic drinks
- •
- marked drowsiness may occur
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- alcohol, sedatives and tranquilizers may increase drowsiness
- •
- be careful when driving a motor vehicle or operating machinery
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- excitability may occur, especially in children
Stop use and ask a doctor if
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- nervousness, dizziness, or sleeplessness occurs
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- fever gets worse or lasts more than 3 days
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- redness or swelling is present
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- new symptoms occur
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- pain, cough or nasal congestion gets worse or last more than 7 days
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- 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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- take every 4 hours, while symptoms persist. Do not take more than 6 packets in 24 hours unless directed by a doctor
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- dissolve contents of one packet into 8 oz. hot water; sip while hot. Consumer entire drink within 10-15 minutes.
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- if using a microwave, add contents of one packet to 8 oz. of cool water; stir briskly before and after heating. Do not overheat.
Other information
Inactive ingredients
Principal Display Panel
NDC 0067-8124-06
THERAFLU®
NIGHTTIME
MULTI-SYMPTOM
SEVERE COLD
ACETAMINOPHEN-PAIN RELIEVER/FEVER REDUCER
DIPHENHYDRAMINE HCl-ANTIHISTAMINE/COUGH SUPPRESSANT
PHENYLEPHRINE HCl-NASAL DECONGESTANT
- •
- NASAL CONGESTION
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- SORE THROAT PAIN
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- COUGH • HEADACHE
- •
- BODY ACHE • FEVER
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- RUNNY NOSE
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- SNEEZING
6 PACKETS
Theraflu® provides powerful relief from your severe cold and flu symptoms.
www.theraflu.com
READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE.
KEEP CARTON FOR REFERENCE. DO NOT DISCARD.
TAMPER EVIDENT INNER UNIT
DO YOU USE IF SEALED THERAFLU PACKET IS TORN OR BROKEN.
Lipton is a registered trademark of the Unilever Group of Companies and is used under license.
Distributed by: Novartis Consumer Health, Inc.
Parsippany, NJ 07054-0622
©2015
Made in Canada
12211
INGREDIENTS AND APPEARANCE
| THERAFLU NIGHTTIME MULTI-SYMPTOM SEVERE COLD POWDER
acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride powder |
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| Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| GSK Consumer Health, Inc. | 129836151 | MANUFACTURE(0067-8124) , ANALYSIS(0067-8124) , PACK(0067-8124) , LABEL(0067-8124) | |