Label: THERAFLU NIGHTTIME SEVERE COLD AND COUGH- acetaminophen, diphenhydramine hcl, phenylephrine hcl powder, for solution
-
Contains inactivated NDC Code(s)
NDC Code(s): 52904-898-03, 52904-898-20 - Packager: Select Corporation
- This is a repackaged label.
- Source NDC Code(s): 0067-7918
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated May 4, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- 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.
- 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 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
- 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
- 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
- Questions or comments?
- SPL UNCLASSIFIED SECTION
-
PRINCIPAL DISPLAY PANEL - 20 Packet Carton
gsk
THERAFLU
SEVERE
COLD & COUGHNIGHTTIME
Acetaminophen
Pain Reliever/Fever ReducerDiphenhydramine HCl
Antihistamine/Cough SuppressantPhenylephrine HCl
Nasal Decongestant- ▶
- Cough
- ▶
- Runny Nose
- ▶
- Nasal Congestion
- ▶
- Sneezing
- ▶
- Sore Throat Pain
- ▶
- Body Ache
- ▶
- Headache
- ▶
- Fever
HONEY LEMON
INFUSED WITH
CHAMOMILE &
WHITE TEA FLAVORS20 PACKETS
-
INGREDIENTS AND APPEARANCE
THERAFLU NIGHTTIME SEVERE COLD AND COUGH
acetaminophen, diphenhydramine hcl, phenylephrine hcl powder, for solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52904-898(NDC:0067-7918) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength acetaminophen (UNII: 362O9ITL9D) (acetaminophen - UNII:362O9ITL9D) acetaminophen 650 mg in 237 mL diphenhydramine hydrochloride (UNII: TC2D6JAD40) (diphenhydramine - UNII:8GTS82S83M) diphenhydramine hydrochloride 25 mg in 237 mL phenylephrine hydrochloride (UNII: 04JA59TNSJ) (phenylephrine - UNII:1WS297W6MV) phenylephrine hydrochloride 10 mg in 237 mL Inactive Ingredients Ingredient Name Strength acesulfame potassium (UNII: 23OV73Q5G9) anhydrous citric acid (UNII: XF417D3PSL) aspartame (UNII: Z0H242BBR1) D&C yellow no. 10 (UNII: 35SW5USQ3G) FD&C blue no. 1 (UNII: H3R47K3TBD) FD&C red no. 40 (UNII: WZB9127XOA) maltodextrin (UNII: 7CVR7L4A2D) silicon dioxide (UNII: ETJ7Z6XBU4) sodium citrate, unspecified form (UNII: 1Q73Q2JULR) sucrose (UNII: C151H8M554) tribasic calcium phosphate (UNII: 91D9GV0Z28) Product Characteristics Color Score Shape Size Flavor HONEY, LEMON (honey lemon infused with chamomile & white tea flavors) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52904-898-03 1 in 1 BLISTER PACK 04/30/2018 1 237 mL in 1 PACKET; Type 0: Not a Combination Product 2 NDC:52904-898-20 20 in 1 CARTON 04/30/2018 2 237 mL in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 04/30/2018 Labeler - Select Corporation (053805599)