SEVERE COLD AND COUGH NIGHTTIME- acetaminophen, diphenhydramine, phenylephrine powder, for solution
Severe Cold and Cough Nighttime by
Drug Labeling and Warnings
Severe Cold and Cough Nighttime by is a Otc medication manufactured, distributed, or labeled by WinCo Foods, LLC. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
- Active ingredients (in each packet)
- Purposes
-
Uses
- ▪
temporarily relieves these symptoms due to a cold:
- ▪ minor aches and pains
- ▪ minor sore throat pain
- ▪ headache
- ▪ nasal and sinus congestion
- ▪ runny nose
- ▪ sneezing
- ▪ itchy nose or throat
- ▪ itchy, watery eyes due to hay fever
- ▪ cough due to minor throat and bronchial irritation
- ▪ temporarily reduces fever
- ▪
temporarily relieves these symptoms due to a cold:
-
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.
- ▪ 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 a 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, asthma 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
- When using this product
-
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 fever, rash or headache that lasts. There could be signs of a serious condition.
- If pregnant or breast- feeding,
- Keep out of reach of children.
-
Directions
- ▪ do not use more than directed
- ▪ take every 4 hours while symptoms persist, not to exceed 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?
-
Additional Information Listed On Other Panels
*Compare to the active ingredients in THERAFLU® Nighttime Severe Cold &Cold
WinCo FOODS
Severe Cold & Cough
Nighttime
ACETAMINOPHEN – PAIN RELIEVER/FEVER REDUER
DIPHENHYDRAMINE HCL - ANTIHISTAMINE/ COUGH SUPPRESSANT
PHENYLEPHRINE HCl – NASAL DECONGESTANT
- Relieves: Nasal Congestion, Sore Throat Pain, Cough, Headache, Body Ache & Fever, Runny Nose & Sneezing
6 PACKETS
Honey Lemon Infused with Chamomile and White Tea Flavors
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 PACKET IS TORN OR BROKEN
The Supermarket Low price Leader ®
100% SATISFACTION GUARANTEE
Comments & Questions?
800-824-1706 www.wincofoods.com
DISTRIBUTED BY:
WINCO FOODS, LLC,
BOISE, ID 83704
*This product is not manufactured or distributed by GSK consumer Healthcare, owner of the registered trademark THERAFLU® Nighttime Severe Cold & Cough.
- Principal Display
-
INGREDIENTS AND APPEARANCE
SEVERE COLD AND COUGH NIGHTTIME
acetaminophen, diphenhydramine, phenylephrine powder, for solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 67091-323 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 650 mg DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) MALTODEXTRIN (UNII: 7CVR7L4A2D) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SUCRALOSE (UNII: 96K6UQ3ZD4) SUCROSE (UNII: C151H8M554) Product Characteristics Color Score Shape Size Flavor HONEY, LEMON Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 67091-323-06 6 in 1 CARTON 08/01/2018 1 1 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 08/01/2018 Labeler - WinCo Foods, LLC (056098817)
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.