RX ACT FLU AND SORE THROAT- acetaminophen,pheniramine maleate, phenylephrine hydrochloride powder, for suspension 
H E B

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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HEB Flu & Sore Throat Drug Facts

Active ingredient (in each packet)

Acetaminophen 650 mg

Pheniramine maleate 20 mg

Phenylephrine hydrochloride 10 mg

Purpose

Pain reliever/fever reducer

Antihistamine

Nasal decongestant

Uses

temporarily relieves these symptoms due to a cold:
minor aches and pains
headache
minor sore throat
nasal congestion
temporarily reduces fever
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
runny nose
sneezing
itchy nose and throat
itchy, watery eyes

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

more than 6 doses in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product

Do not use

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.
to make a child sleepy

Ask a doctor before use if you have

liver disease
heart disease
high blood pressure
thyroid disease
diabetes
glaucoma
a breathing problem such as emphysema, asthma or chronic bronchitis
trouble urinating due to an enlarged prostate gland
a sodium-restricted diet

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 use more than directed
avoid alcoholic drinks
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

you get nervous, dizzy or sleepless
pain or nasal congestion gets worse or lasts more than 7 days
fever gets worse or lasts more than 3 days
redness or swelling is present
new symptoms occur
sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. Quick 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 – see Liver warning
take every 4 hours; do not exceed 6 packets in 24 hours or as directed by a doctor

adults and children 12 years of age and over

dissolve contents of one packet in 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.

children 4 to under 12 years of age

consult a doctor

children under 4 years of age

do not use

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 5 mg and sodium 46 mg
store at 20º-25ºC (68º-77ºF)

Inactive ingredients

acesulfame potassium, citric acid, colloidal silicon dioxide, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, flavors, maltodextrin, medium chain triglycerides, mono- and diglycerides, pregelatinized starch, silicon dioxide, sodium chloride, sodium citrate, soy lecithin, sucrose, triacetin, tribasic calcium phosphate

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to Theraflu® Flu & Sore Throat active ingredients

Flu & Sore Throat

Multi-Symptom

Pain Reliever–Fever Reducer (Acetaminophen)

Antihistamine (Pheniramine Maleate)

Nasal Decongestant (Phenylephrine HCl)

Sore Throat

Body Ache

Headache

Nasal Congestion

Fever

Runny Nose

Natural Apple Cinnamon Flavor

See New Warnings Information

Gluten Free

Flu & Sore Throat Carton Image 1

Flu & Sore Throat Carton Image 1

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Flu & Sore Throat Carton Image 2

RX ACT FLU AND SORE THROAT 
acetaminophen,pheniramine maleate, phenylephrine hydrochloride powder, for suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-133
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 15000 mg
PHENIRAMINE MALEATE (UNII: NYW905655B) (PHENIRAMINE - UNII:134FM9ZZ6M) PHENIRAMINE MALEATE20 mg  in 15000 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 15000 mg
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
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 CHLORIDE (UNII: 451W47IQ8X)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
SUCROSE (UNII: C151H8M554)  
TRIACETIN (UNII: XHX3C3X673)  
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
Product Characteristics
ColorYELLOW (light) Score    
ShapeSize
FlavorAPPLEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37808-133-916 in 1 CARTON12/29/201010/25/2014
115000 mg in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/29/201010/25/2014
Labeler - H E B (007924756)

Revised: 11/2017
 
H E B