Label: NIGHTTIME SEVERE COLD AND COUGH- acetaminophen, diphenhydramine, phenylephrine powder, for solution
- NDC Code(s): 68163-541-06
- Packager: RARITAN PHARMACEUTICALS INC
- 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 September 1, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- 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
-
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?
-
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
-
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)