NIGHTTIME SEVERE COLD AND COUGH- acetaminophen, diphenhydramine, phenylephrine powder, for solution 
RARITAN PHARMACEUTICALS INC

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.

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DRx Choice Nighttime Severe Cold & Cough Chamomile & White Tea Flavors 6 Packets

Active ingredients (in each packet)

Acetaminophen 650 mg

Diphenhydramine hydrochloride 25 mg

Phenylephrine hydrochloride 10 mg

Purposes

Pain reliever / fever reducer

Antihistamine / Cough Suppressant

Nasal Decongestant

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

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 fever, rash or headache that lasts. There could be signs of a serious condition.

If pregnant or breast- feeding,

ask a health care professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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

each packet contains: potassium 6 mg
store at room temperature. Protect from excessive heat and moisture.

Inactive ingredients

citric acid, FD& C Yellow No. 6, flavors, maltodextrin, potassium chloride, silica, sucralose, sucrose,

Questions or comments?

1-866-467-2748

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

DRx Nighttime Severe Cold and Cough Honey Lemon Flavor
NIGHTTIME SEVERE COLD AND COUGH 
acetaminophen, diphenhydramine, phenylephrine powder, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68163-541
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorHONEY, LEMONImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68163-541-066 in 1 CARTON03/22/2019
11 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/22/2019
Labeler - RARITAN PHARMACEUTICALS INC (127602287)

Revised: 7/2022
Document Id: 0623d0fd-931b-4c79-b6ad-47b32a8396e2
Set id: 9819155b-2713-42be-867e-16605e7643d0
Version: 4
Effective Time: 20220704
 
RARITAN PHARMACEUTICALS INC