Label: SEVERE COLD AND COUGH DAYTIME- acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride powder, for solution
- NDC Code(s): 68163-540-06
- Packager: RARITAN PHARMACEUTICALS INC
- Category: HUMAN OTC DRUG LABEL
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 healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients (in each packet)
- Purposes
- 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.
- ▪
- 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
- ▪
- trouble urinating due to an enlarged prostate gland
- ▪
- cough that occurs with too much phlegm (mucus)
- ▪
- cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema
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?
-
Package/Label Principal Display Panel
NDC# 68163-540-06
Compare to the active ingredients in Theraflu® Daytime Severe Cold & Cough*
Day Time
Severe Cold & Cough
Acetaminophen
Pain Reliever/Fever Reducer
Dextromethorphan HBr
Cough Suppressant
Phenylephrine HCl
Nasal Decongestant
- •
- Aspartame free
- •
- Sodium free
Relieves
- •
- Body Ache
- •
- Cough
- •
- Fever
- •
- Headache
- •
- Nasal Congestion
- •
- Sore Throat Pain
6 PACKETS
BERRY FLAVOR
Infused With Menthol & Green Tea Flavor
TAMPER EVIDENT: DO NOT USE INNER SEALED PACKET IF TORN
Manufactured by:
Raritan Pharmaceuticals
8 Joanna Court,
East Brunswick, NJ 08816
This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Theraflu® Daytime Severe Cold & Cough.
-
INGREDIENTS AND APPEARANCE
SEVERE COLD AND COUGH DAYTIME
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride powder, for solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68163-540 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 650 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) MALTODEXTRIN (UNII: 7CVR7L4A2D) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SUCRALOSE (UNII: 96K6UQ3ZD4) SUCROSE (UNII: C151H8M554) Product Characteristics Color WHITE (mixture of white to light to dark red particles) , RED Score Shape Size Flavor BERRY, MENTHOL Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68163-540-06 6 in 1 CARTON; Type 0: Not a Combination Product 03/14/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 03/14/2019 Labeler - RARITAN PHARMACEUTICALS INC (127602287)