NIGHTTIME SEVERE COLD AND COUGH- acetaminophen, diphenhydramine, phenylephrine powder, for solution
Nighttime Severe Cold and Cough by
Drug Labeling and Warnings
Nighttime Severe Cold and Cough by is a Otc medication manufactured, distributed, or labeled by RARITAN PHARMACEUTICALS INC. 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.
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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?
-
Principal Display Panels
*Compare to the active ingredients in Theraflu® Nighttime Severe Cold & Cough*
NDC# 68163-541-06
Nighttime
Severe Cold & Cough
ACETAMINOPHEN
PAIN RELIEVER/FEVER REDUER
DIPHENHYDRAMINE HCl
ANTIHISTAMINE/ COUGH SUPPRESSANT
PHENYLEPHRINE HCl
NASAL DECONGESTANT
- Aspartame free
- Sodium Free
Relieves:
Body Ache & Fever
- Cough
- Fever
- Headache
- Nasal Congestion
- Runny Nose
- Sneezing
- Sore Throat Pain
6 PACKETS
Honey Lemon Flavor
Infused with Chamomile & White Tea Flavors
TAMPER EVIDENT: DO NOT USE IF INNER SEALED PACKET IS TORN
Manufactured by:
Raritan Pharmaceuticals
8 Joanna Court
East Brunswick, NJ 08816
*This product is not manufactured or distributed by GSK consumer Healthcare, owner of the registered trademark THERAFLU® Nighttime Severe Cold & Cough.
- Display
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INGREDIENTS AND APPEARANCE
NIGHTTIME SEVERE COLD AND COUGH
acetaminophen, diphenhydramine, phenylephrine powder, for solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 68163-541 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: 68163-541-06 6 in 1 CARTON 03/22/2019 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 03/22/2019 Labeler - RARITAN PHARMACEUTICALS INC (127602287)
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