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NDC 00067-7916-06 Theraflu 650; 20; 10 mg/1; mg/1; mg/1 Details
Theraflu 650; 20; 10 mg/1; mg/1; mg/1
Theraflu is a ORAL POWDER, FOR SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC. The primary component is ACETAMINOPHEN; PHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE.
Product Information
| NDC | 00067-7916 |
|---|---|
| Product ID | 0067-7916_d8ddbe3f-aaa9-46a9-a96f-11670daec9ac |
| Associated GPIs | 43994003323050 |
| GCN Sequence Number | 059118 |
| GCN Sequence Number Description | pheniramine/p-eph/acetaminophn PACKET 20-10-650 ORAL |
| HIC3 | B3O |
| HIC3 Description | 1ST GEN ANTIHISTAMINE-DECONGESTANT-ANALGESIC COMB |
| GCN | 24651 |
| HICL Sequence Number | 005286 |
| HICL Sequence Number Description | PHENIRAMINE MALEATE/PHENYLEPHRINE HCL/ACETAMINOPHEN |
| Brand/Generic | Brand |
| Proprietary Name | Theraflu |
| Proprietary Name Suffix | Flu and Sore Throat |
| Non-Proprietary Name | Acetaminophen, Pheniramine Maleate, Phenylephrine HCl |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | POWDER, FOR SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 650; 20; 10 |
| Active Ingredient Units | mg/1; mg/1; mg/1 |
| Substance Name | ACETAMINOPHEN; PHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE |
| Labeler Name | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC |
| Pharmaceutical Class | Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | 2022-12-31 |
Package
Package Images
NDC 00067-7916-06 (00067791606)
| NDC Package Code | 0067-7916-06 |
|---|---|
| Billing NDC | 00067791606 |
| Package | 6 PACKET in 1 CARTON (0067-7916-06) / 1 POWDER, FOR SOLUTION in 1 PACKET (0067-7916-01) |
| Marketing Start Date | 2005-05-13 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 44e1e7b4-d867-4aab-9a51-7a72456eeaa0 Details
Active ingredients (in each packet)
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 a 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
- •
- glaucoma
- •
- trouble urinating due to an enlarged prostate gland
- •
- a breathing problem such as emphysema or chronic bronchitis
- •
- a sodium-restricted diet
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
- •
- may cause drowsiness
- •
- alcohol, sedatives and tranquilizers may increase drowsiness
- •
- be careful when driving a motor vehicle or operating machinery
- •
- excitability may occur, especially in children
Directions
- •
- do not use more than directed
- •
- take every 4 hours, while symptoms persist. Do not take more than 5 packets in 24 hours unless directed by a doctor.
|
Age |
Dose |
|
adults and children 12 years of age and over |
one packet |
|
children under 12 years of age |
do not use |
- •
- dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.
- •
- 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
Additional information
READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE.
KEEP CARTON FOR REFERENCE. DO NOT DISCARD.
TAMPER EVIDENT INNER UNIT
DO NOT USE IF SEALED THERAFLU PACKET IS TORN OR BROKEN.
1-855-328-5259
Distributed by: GSK Consumer Healthcare
Warren, NJ 07059
©2019 GSK group of companies or its licensor.
Trademarks are owned by or licensed to the GSK group of companies.
FLU & SORE THROAT
NASAL CONGESTION
SORE THROAT PAIN
HEADACHE
FEVER
BODY ACHES
RUNNY NOSE
Principal Display Panel
INGREDIENTS AND APPEARANCE
| THERAFLU
FLU AND SORE THROAT
acetaminophen, pheniramine maleate, phenylephrine hcl powder, for solution |
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| Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263) |
Revised: 8/2020
Document Id: d8ddbe3f-aaa9-46a9-a96f-11670daec9ac
Set id: 44e1e7b4-d867-4aab-9a51-7a72456eeaa0
Version: 6
Effective Time: 20200814