ALLERGY PLUS SINUS HEADACHE- acetaminophen, diphenhydramine hcl, phenylephrine hcl tablet, coated

Allergy plus Sinus Headache by

Drug Labeling and Warnings

Allergy plus Sinus Headache by is a Otc medication manufactured, distributed, or labeled by Spirit Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients (in each caplet)

Acetaminophen 325 mg

Diphenhydramine HCl 12.5 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever

Antihistamine

Nasal decongestant

Uses

temporarily relieves these symptoms of hay fever and the common cold:
runny nose
sneezing
headache
minor aches and pains
nasal congestion
temporarily relieves these additional symptoms of hay
fever:
itching of the nose or throat
itchy, watery eyes

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
3 or more alcoholic drinks every day while using this product
with other drugs containing acetaminophen

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
blisters
rash
skin reddening
If a skin reaction occurs, stop use and seek medical help right away.

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.
with any other product containing diphenhydramine, even one used on 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 an MAOI, ask a doctor or pharmacist before taking this product.
if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

liver disease
glaucoma
thyroid disease
heart disease
diabetes
high blood pressure
difficulty in urination due to enlargement of the prostate gland
a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin
taking sedatives or tranquilizers

When using this product

do not exceed recommended dosage
excitability may occur, especially in children
marked drowsiness may occur
alcohol, sedatives, and tranquilizers may increase drowsiness
use caution when driving a motor vehicle or operating machinery
avoid alcoholic beverages

Stop use and ask a doctor if

nervousness, dizziness, or sleeplessness occur
pain or nasal congestion gets worse or lasts more than 7 days
new symptoms occur
fever gets worse or lasts more than 3 days
redness or swelling is present

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. 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
adults and children 12 years and over
take 2 caplets every 4 hours
do not take more than 10 caplets in 24 hours
children under 12 years: ask a doctor

Other information

store at 25oC (77oF); excursions permitted between 15o-30oC (59o-86oF)

Inactive Ingredients

microcrystalline cellulose, pregelatinized starch, croscarmellose sodium,
polyvinyl pyrrolidone, colloidal silicon dioxide, stearic acid powder, polyvinyl alcohol, polyethylene glycol, titanium dioxide, talc, tartrazine yellow lake, brilliant blue lake, indigo carmine lake

Questions or comments?

1-888-333-9792

SPL UNCLASSIFIED SECTION

READ AND KEEP CARTON FOR COMPLETE WARNINGS AND INFORMATION

TAMPER EVIDENT : DO NOT USE IF CARTON IS OPENED OR SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

SPL UNCLASSIFIED SECTION

Distributed By:
Spirit Pharmaceuticals, LLC
Ronkonkoma, NY 11779

ORIG 05/21

Made in India

label and carton

label

carton

INGREDIENTS AND APPEARANCE

ALLERGY PLUS SINUS HEADACHE 
acetaminophen, diphenhydramine hcl, phenylephrine hcl tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68210-4190
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	12.5 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE	5 mg

Inactive Ingredients
Ingredient Name	Strength
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
STARCH, POTATO (UNII: 8I089SAH3T)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
PYRROLIDINE (UNII: LJU5627FYV)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TALC (UNII: 7SEV7J4R1U)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)

Product Characteristics
Color	green	Score	no score
Shape	CAPSULE	Size	19mm
Flavor		Imprint Code	S504
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68210-4190-1	1 in 1 CARTON	11/11/2021
1		12 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	11/11/2021

Labeler - Spirit Pharmaceuticals LLC (179621011)