Label: EQUALINE MULTI SYMPTOM FLU AND SEVERE COLD DAYTIME- acetaminophen, dextromethorphan hbr, phenylephrine hcl powder, for solution
- NDC Code(s): 41163-908-91
- Packager: United Natural Foods, Inc. dba UNFI
- 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 August 23, 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
-
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 have ever had an allergic reaction to this product or any of its ingredients
- •
- 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
- •
- a sodium-restricted diet
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 serious condition.
-
Directions
- •
- do not use more than directed (see overdose warning)
- •
- take every 4 hours, while symptoms persist. Do not take more than 6 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
compare to Theraflu® Multi-Symptom Severe Cold active ingredients
EQUALINE®
multi-symptom
flu & severe cold
daytime
acetaminophen (pain reliever/fever reducer)
dextromethorphan HBr (cough suppressant)
phenylephrine HCl (nasal decongestant)
relieves:
● nasal & sinus congestion
● cough
● body ache
● sore throat pain
● headache
● fever
green tea & honey lemon flavors
6 packets
-
INGREDIENTS AND APPEARANCE
EQUALINE MULTI SYMPTOM FLU AND SEVERE COLD DAYTIME
acetaminophen, dextromethorphan hbr, phenylephrine hcl powder, for solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41163-908 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 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 ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) ASPARTAME (UNII: Z0H242BBR1) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) MALTODEXTRIN (UNII: 7CVR7L4A2D) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) SUCROSE (UNII: C151H8M554) TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) Product Characteristics Color Score Shape Size Flavor HONEY (Lemon and Green Tea) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41163-908-91 6 in 1 CARTON; Type 0: Not a Combination Product 07/28/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 07/28/2016 Labeler - United Natural Foods, Inc. dba UNFI (943556183)
